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OPTIVIS SUMMARY 2 

AAREN SCIENTIFIC INC. 

Section Title 

Cover Page………………………………………………………………. 1 

Table of Contents……………………………………………………….. 2 

I. General Information…………………………………………………….. 4 

A. Device Generic Name……………………………………………... 4 

B. Device Trade Name……………………………………………….. 4 

C. Principle Investigators……………………………………………. 4 

D. Sponsor Information………………………………………………. 4 

II. Introduction……………………………………………………………….. 5 

III. Background………………………………………………………………. 5 

IV. Lens Description……………………………………………………........ 5 

A. Through Focus Curves…………………………………………….. 6 

B. Recommended Implantation System…………………………….. 7 

C. Intended Function………………………………………………….. 7 

D. Competitor Characteristics………………………………………... 7 

V. Study Objective………………………………………………………….. 9 

18May2011 Confidential Information 

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VI. Study Lens Indication…………………………………………………… 10 

VII. Directions for Use……………………………………………………….. 10 

VIII. Alternative Treatments………………………………………………….. 13 

IX. Study Duration…………………………………………………………… 13 

X. Study Method…………………………………………………………….. 13 

A. Evaluation Criteria………………………………………………….. 13 

B. Visits & Procedures………………………………………………… 14 

C. Study Population…………………………………………………… 14 

XI. Inclusion Criteria……………………………………………………........ 14 

XII. Exclusion Criteria………………………………………………………… 15 

XIII. Visit Schedule……………………………………………………………. 15 

A. Preoperative………………………………………………………… 16 

B. Summary of Preoperative Procedures…………………………… 16 

C. Operative……………………………………………………………. 17 

D. Operative Report…………………………………………………… 17 

E. Post Operative……………………………………………………… 18



F. Pupil Size……………………………………………………………. 19 

G. Other Evaluations………………………………………………….. 19 

H. Post Operative Reports……………………………………………. 19 

XIV. Performance Criteria…………………………………………………….. 20 

XV. Results……………………………………………………………………. 20 

A. One-month…………………………………………………………….. 21 

B. Three-month…………………………………………………………... 22 

C. Six-month……………………………………………………………… 23 

D. Subject Satisfaction………………………………………………….. 24 

E. Data Summary………………………………………………………... 25 

F. Serial Numbers……………………………………………………….. 26 

G. Conclusion……………………………………………………………. 26 

XVI. Literature Review………………………………………………………… 26 

XVII. Attachments………………………………………………………………. 27 

A. Data Report……………………………………………………………. 27 

B. Serial Numbers ……………………………………………………….. 35 

C. Literature Review……………………………………………………… 39 

18May2011 Confidential Information



I. GENERAL INFORMATION 

A. DEVICE GENERIC NAME 

Multifocal Progressive Diffractive Lens (MPDL)- One-Piece Hydrophillic Acrylic 

Posterior Chamber Intraocular Lens 

B. DEVICE TRADE NAME 

OptiVis Intraocular Lens 

C. PRINCIPLE INVESTIGATORS 

Dr. Matteo Piovella 

Centro Microchirurgia Ambulatoriale srl 

Via Donizetti 24 

20052 Monza 

Italy 

Dr. Jean-Michel Bosc 

Cabinet d’Ophtalmologie 

88 rue des Hauts Pavés 

44000 Nantes 

France 

D. SPONSOR INFORMATION 

Aaren Scientific Inc. 

4290 East Brickell St., Bldg. A 

Ontario, CA 91761 USA 

Tel: 909-937-1033 

Fax: 909-937-1088 




II. INTRODUCTION 

Aaren Scientific Inc. conducted a multicenter, international clinical study using 

the OptiVis IOL. The purpose of this study was to evaluate the efficacy of the 

OptiVis Multifocal IOL in subjects undergoing bilateral crystalline lens 

replacement following extraction by phacoemulsification. 

The study started with a total of 121 eyes from 62 subjects implanted with the 

OptiVis lens from two sites in Europe. The mean age for the subjects was 

70.43 ± 6.33 years. Of the 121 eyes that were implanted, 108 eyes (54 subjects) 

had completed the 1-month postoperative visit, 94 eyes (47 subjects) completed 

the 3-month postoperative visit, and 88 eyes (44 subjects) completed the 6month 

postoperative visit. Subjects who were implanted with the lens were 

considered enrolled in the study, however, only data from subjects with bilateral 

implants were considered. 

III. BACKGROUND 

Intraocular lenses (IOLs) are routinely implanted after cataract extraction. 

Cataract surgical techniques are constantly developing due to innovations in 

surgical instrumentation and IOL manufacturing processes. Material 

development, surgical instrumentation and improvement of the optical quality of 

IOLs have advanced extensively during the past several years. 

Monofocal IOLs are used to correct distance visual acuity after lensectomy. 

There is a disadvantage to these lenses because of the loss of accommodation 

and the ability to read at near distances without spectacles is lost. A multifocal 

IOL (MIOL) is a valuable addition to the existing therapies to correct refractive 

error and create a state of pseudo-accommodation. 

IV. LENS DESCRIPTION 

The OptiVis Multifocal Progressive Diffractive (MPDL) Intraocular Lens (IOL) is 

designed to provide cataract patients with extended vision range compared to 

regular Monofocal (single vision) lenses. The lens provides two distinct images: 

distance (far) and near images, and extended intermediate vision range. The 

distance image provides the patients with distance vision similar to commercially 

available MIOLs. The near image allows subjects to see a near object at about 

35 cm. Labeling diopter power of the MPDL is defined by power of distance 

image. 

The OptiVis MPDL has a diffractive-refractive posterior surface design and a 

spherical anterior surface. The patented diffractive-refractive design consists of 

multiple zones: a progressive refractive intermediate-distance center zone with 

1.5 mm diameter; an apodized diffractive bifocal annual zone for Distance and 




Near within 1.5 – 3.8 mm diameter; and an aspeheric refractive zone for Distance 

outside 3.8 mm. The OptiVis MPDL is made from approved hydrophilic acrylic 

material. 

A. THROUGH FOCUS CURVES 

The average through focus monochromatic response function (TFR) curves 

for 20.0 D multifocal intraocular lenses are shown in Figure 1 below for 

different pupil sizes. The defocus is expressed in equivalent spectacle power 

in order to display the effect of the IOL power ADD in spectacle power. The 

peak at zero diopters corresponds to the distance focus; the peak at +2.7 

diopters corresponds to the near focus (for an IOL power add of +3.75 D). 

FIGURE 1: THROUGH FOCUS CURVES 

Characteristic Multifocal IOL 

Overall Diameter 11.0 mm 

Optic Diameter 6.0 mm 

Optic Material Hydrophilic Acrylic 

Refractive Index 1.46 

Optic Type Multifocal 

Optic Design Multifocal (hybrid with 

refractive and diffractive 

properties) aspheric biconvex 

Haptic Material Single-piece (i.e., monoblock) 

Haptic Shape Footplate 4pt 

A-Constant with 

Nomogram 

118.1 

Through Focus MTF (50 Ip/mm[20/40] in ISO EYE Model 

at different apertures 

Each lens is packaged hydrated in a glass vial and sealed in a peel-pouch. 

The lens is sterile as long as the package has not been opened or damaged 

and the shelf-life expiration date has not been reached. 




B. IMPLANTATION SYSTEMS 

The multifocal lenses are recommended to be implanted using the 

commercially available Naviject 2.2 1P system from Medicel AG. 

IOL Implantation Systems 

Multifocal Naviject 2.2 1P 

C. INTENDED FUNCTION 

The OptiVis IOL is a single-piece (“monobloc”) optical implant for the 

correction of aphakia following extraction of the cataractous human crystalline 

lens. It is designed to provide simultaneous distance, intermediate and near 

vision in comparison to conventional monofocal lenses that provide distance 

vision only. As such, OptiVis offers the restoration of visual function after 

cataract surgery with the potential to significantly reduce spectacle 

dependence. 

D. COMPETITOR CHARACTERISTICS 

The table below lists the currently marketed MIOLs with an explanation of 

their multifocal optical characteristics. All competitor diffractive multifocal IOL 

designs do not have provisions for intermediate vision and are thus 

referenced as 1 st generation diffractive MIOLs. 

Table 1: Marketed MIOL as of August 2009 

Multifocal IOL 

ReZOOM MIOL. 

Model NXG1 


Tecnis MIOL. Model 

ZM900 

Manufacturer Abbott Medical Optics Abbott Medical Optics 

Optic material Hydrophobic acrylic Hydrophobic acrylic 

Optic body - Multifocal anterior surface 

- Prolate aspheric anterior surface 

- Spherical posterior surface 

- Bifocal posterior surface 

Multifocal Refractive: 

Diffractive: 

Optic type Zonal-progressive design with Full surface blazed shaped diffractive 

continuous power variation from bifocal with 0-order for distance focus 

distance through intermediate to near and (-1)-order for near focus with equal 

light split between distance and near



Key multifocal 

specifications 

Multifocal IOL 

- 3.5 D IOL Add, 2.6 Effective Add. 

- Provision for intermediate in 

addition to distance and near 

- Near zones aspherization to reduce 

halo 

- Distance and intermediate powers 

within 2 mm but no near power 

- Utilizes 100% of light for imaging 

- Anterior placement of multifocal 

surface positions it further away from 

the eye nodal point. 

ReStor MIOL, 

Model SA50D3 

and others 


foci 

- 4.0 D IOL Add, 3D Effective Add. 

- No provision for intermediate vision 

- Front surface aspherization to 

improve contrast at distance with large 

pupils for well centered lens placement 

inside the Eye. 

- Pupil independency to maintain 

distance and near vision for the full 

range of pupils 

- Utilizes 81% of light for imaging. 19% 

of light is out-of-focus 

- Posterior placement of multifocal 

surface positions it closest to the eye 

nodal point. 

AcriLisa MIOL 

Manufacturer Alcon Acri.Tec - Zeiss 

Optic material Hydrophobic acrylic Hydrophilic acrylic 

Optic body - Bifocal anterior surface 

- Bifocal anterior surface 

- Spherical posterior surface 

- Prolate aspheric of base surface of 

the diffraction zone and lens 

periphery 

- Prolate aspheric posterior surface 

Multifocal Diffractive: 

Refractive-diffractive: 

optic type Central zone blazed shaped 

Full surface diffractive bifocal. Main 

diffractive bifocal (3.6 mm diameter) sub-zones function as grooves of a 

with 0-order for distance focus and (- blazed diffraction zone by proving 0- 

1)-order for near focus with apodized order for distance focus and (-1)-order 

light split between distance and near 

foci, i. e. increased percentage of 

light to distance focus towards 

diffractive zone periphery 

for near focus.



Key 

multifocal 

specifications 

V. STUDY OBJECTIVE 

The increase in light split towards 

distance focus is achieved by 

reducing the groove heights towards 

diffractive bifocal zone periphery 

- 4.0 D IOL Add, 3.2 Effective Add 

- 3.0 D IOL Add, 2.3 Effective Add. 

ReSTOR MIOL with Reduced Add 

power design was introduced in effort 

to improve intermediate by bringing 

Far and Near foci closer to each 

other. 

- No provision for intermediate vision. 

- Refraction distance power outside 

bifocal diffraction zone 

- Apodized bifocal design for 

progressively increasing distance 

dominance towards lens periphery. 

Distance to Near: 60% : 30% at 3 mm; 

75% : 18% at 4 mm pupil 

- Model SN6AD3 incorporated 

aspheric base surface and lens 

periphery outside the diffraction zone 

to improve contrast at distance at 

large pupil for well centered lens 

placement inside the eye 




Phase sub-zones function as height of 

blazes diffraction to phase shift 

between main sub-zones. It is shaped 

to provide refractive power coinciding 

with 0-order diffraction. This results in 

distance focus to be formed by 

refraction and diffraction though mainly 

by diffraction because phase subzones 

occupy only small fraction of 

surface as compared with main subzones. 

- 3.75 D IOL Add, 2.7 D Effective Add 

- No provision for intermediate vision 

- 55% distance and 30% near (based 

upon 65% to 35% bifocal split of 85% 

of usable light), ~15% is out-of-focus; 

- Presence of refractive phase subzones 

increases the use of light by the 

bifocal design from 81% to ~85%); 

- Posterior surface aspherization to 

improve contrast at distance with large 

pupils for well centered lens position 

inside the eye 




The study objective was to evaluate the efficacy of the OptiVis IOL and to 

establish and document the following endpoints: 

1. Monocular uncorrected and best corrected distance visual acuity under 

photopic conditions 




2. Monocular distance corrected intermediate visual acuity under photopic 

conditions 

3. Monocular distance corrected near visual acuity under photopic conditions 

at both a fixed distance and the subject’s preferred distance 

4. Binocular uncorrected distance visual acuity under photopic conditions 

5. Binocular best corrected distance visual acuity under photopic conditions 

6. Binocular uncorrected intermediate visual acuity under photopic conditions 

7. Binocular distance corrected intermediate visual acuity under photopic 

conditions 

8. Binocular uncorrected near visual acuity under photopic conditions 

9. Binocular distance corrected near visual acuity under photopic conditions 

10. Lens stability 

11. Quality of life and other subjective response ratings 

VI. STUDY LENS INDICATION 

Aaren Scientific’s OptiVis IOLs are intended for primary implantation in the 

capsular bag of the eye for the visual correction of aphakia in adult patients in 

whom a cataractous lens has been removed by phacoemulsification. 

VII. DIRECTIONS FOR USE 

Description: 

Aaren Scientific Multifocal Progressive Diffractive Posterior Chamber 

Lenses are one-piece multifocal IOLs designed to be implanted in the 

Capsular Bag following cataract extraction. The optic is biconvex design 

with multifocal diffractive zones on the posterior surface. It is made from 

an optically clear hydrophilic acrylic material to which an UV-absorbing 

component has been added. 

Indications: 

Aaren Scientific lenses are intended for primary or secondary implantation 

in the posterior chamber in patients where a cataractous lens has been 

removed by cataract extraction. Use of the lenses is especially appropriate 

in patients who cannot tolerate contact lenses, those who would not be 

candidates for cataract spectacles, or for patients requiring an intraocular 

lens for occupational or other reasons. 

Caution: 

Patients with any of the following conditions may not be suitable 

candidates for implantation of the posterior chamber lens: 

1. Chronic uveitis, iritis, iridocyclytis or rubeosis iridis. 

2. Congenital bilateral cataracts. 

3. Excessive vitreous pressure. 




4. Medically uncontrollable glaucoma. 

5. Ruptured posterior capsule or zonular separations. 

6. Patients with only one eye with potentially good vision. 

7. Proliferative diabetic retinopathy. 

8. Endothelial corneal dystrophy. 

9. Operative vitreous loss. 

10. Aniridia. 

11. Implantation of posterior chamber lenses in the anterior chamber has 

been shown to be unsafe and should not be performed with posterior 

chamber lenses. 

12. The requirement for a secondary iridectomy for pupillary block may be 

prevented by one or more iridectomies at the time of IOL implantation. 

This preventative measure is better known for anterior chamber and iris 

fixation models. It has also been determined to apply to posterior chamber 

models. 

13. Marked microphthalmos. 

14. Recurrent anterior or posterior segment inflammation of unknown etiology. 

15. Rubella cataract. 

Warnings: 

Physicians considering lens implantation under any of the following 

circumstances should weigh the potential risk/benefit ratio: 

1. Improper handling of this lens may cause damage to the haptics and the 

optics. 

2. Patients in whom the intraocular lens may affect the ability to observe, 

diagnose, or treat posterior segment diseases. 

3. Surgical difficulties at the time of cataract extraction which might increase 

the potential for complications (e.g., persistent bleeding, significant iris 

damage, uncontrolled positive pressure, or significant vitreous prolapse or 

loss). 

4. A distorted eye due to previous trauma or developmental defect in which 

appropriate support of the IOL is not possible. 

5. Circumstances that would result in damage to the endothelium during 

implantation. 

6. Suspected microbial infection. 

7. Recurrent ocular disease (e.g., uveitis, diabetic retinopathy, or glaucoma). 




8. The long-term effects of intraocular lens implantation have not been 

determined. Therefore, physicians should continue to monitor implant 

patients postoperatively. 

Precautions: 

1. Do not autoclave the intraocular lens. 

2. Do not resterilize by any method. 

3. Store at room temperature. 

4. Do not freeze or leave in sunlight. 

5. Use only sterile balanced salt solution for rinsing or soaking of lens. 

6. A high level of surgical skill is required for intraocular lens 

implantation. A surgeon should have observed and/or assisted on 

numerous surgical implantations and successfully completed one or 

more courses on intraocular lens implantation before attempting to 

implant intraocular lenses. 

Lens Power Calculation: 

The power of the lens to be implanted should be determined 

preoperatively. The suggested A-Constant provided on the outer label is 

presented as a reference for implant power calculation. It is recommended 

that the surgeon verify the power calculation with the manufacturer of this 

product. It is important for the surgeon to establish a personalized lens 

power calculation for the product. 

Multifocal IOL power calculation consists of a three-step process: 

1. Calculate the Base Monofocal IOL Power ‘P(Base)’ by utilizing an 

acceptable physician procedure (A=118.1). No power rounding to the 

half-diopter increments should be performed at this step. 

2. Multifocal IOL Power ‘P(Multi)’ is calculated by applying the following 

nomogram for the range of powers between 16.0 D and 25.0 D: 

P(Multi) = P(Base) - ∆P, where ∆P = 0.085 x P(Base) – 0.87 

3. The calculated power ‘P(Multi)’ of multifocal IOL is then rounded to 

the closest half-diopter increment for the labeled IOL power selection. 

Instructions for Use: 

NOTE: To avoid dehydration, leave lens immersed in vial until ready to use. 

Lens should be used within 3 minutes after removal from vial. 

1. A variety of surgical techniques may be employed during the implantation 

of an intraocular lens. The surgeon should select a procedure which is 

appropriate for the patient. 

2. Check the label on the lens box for proper lens model, dioptric power and 

expiration date. 

3. Open the package and verify dioptric power of the lens. 

4. Orient lens for insertion. 




How Supplied: 

Aaren Scientific Multifocal Progressive Diffractive Hydrophilic Acrylic 

Posterior Chamber Intraocular Lens is supplied sterile, non-pyrogenic and 

hydrated in USP balanced salt solution within its own vial and sterilization 

pouch. Sterility is assured provided the sterilization pouch seal has not 

been compromised or the pouch has been punctured. 

Sterility Date: 

The expiration date is clearly indicated on the outside of the box. 

VIII. ALTERNATIVE TREATMENTS 

There are non-investigational (approved and marketed) alternative devices 

available for treatment of cataracts. These include a variety of FDA-approved 

IOLs manufactured by domestic or international companies. Some of the 

approved lenses are made from a soft material such as the material used in the 

lens for this study. Other approved lenses are manufactured from a rigid acrylic 

plastic or from silicone. There are a variety of designs of these lenses, although 

most are intended to be placed in the same area within the eye as is the lens 

from this study and to have the same end result. 

Another alternative is to wear thick spectacles or contact lenses following 

removal of the cataract. 

IX. STUDY DURATION 

The study was conducted over a six-month period, starting at the date of 

implantation. For each subject, the physician selected the first operative eye 

according to his/her discretion. All subjects had bilateral cataract surgery, with 

the second eye surgery at least one week and no more than four weeks after the 

first eye surgery. After each surgery, each subject was examined 7-14 days 

postoperatively. All subjects were then evaluated postoperatively at 30 days (1 

month) , 90 days (3 months), and 180 days (6 months) following the second eye 

surgery. All subjects were treated to the normal standard of care for cataract 

surgery in addition to the specific evaluations specified in the protocol. 

X. STUDY METHOD 

A. EVALUATION CRITERIA 

Key evaluation criteria included (a) uncorrected and best-corrected distance 

visual acuity, (b) uncorrected and distance-corrected intermediate visual 




acuity (70 cm), (c) uncorrected, distance-corrected near visual acuity (40 

cm) under photopic conditions, (d) subject satisfaction. 

B. VISITS AND PROCEDURES 

The preoperative visit included an assessment of subject qualifications for 

inclusion according to the protocol inclusion/exclusion criteria. Key 

preoperative data collection included medical history, visual acuities, 

refraction, keratometry, biomicroscopic slit lamp findings, pupil size and 

subject questionnaires. The operative visit included all surgical procedures 

standard to cataract surgery and IOL implantation. Key data was recorded 

from the surgical procedure including lens serial number, lens power, 

incision size, medications, and complications. Postoperative key data 

collection included visual acuities, refraction, keratometry, slit lamp findings, 

complications, adverse events, and subject questionnaires. The same 

procedures applied to both eyes. 

C. STUDY POPULATION 

This study included only subjects undergoing bilateral primary 

phacoemulsification cataract extraction and lens implantation and who met 

the inclusion and exclusion criteria. 

XI. INCLUSION CRITERIA 

Age 18 or greater 

Bilateral cataracts for which phacoemulsification extraction and posterior 

IOL implantation has been planned for both eyes 

Visual potential of 20/30 or better in each eye after cataract removal and 

IOL implantation 

Preoperative BCDVA worse than Snellen 20/40 (or worse than 20/30 in 

the presence of glare as measured using a Snellen chart with BAT at 

medium) 

Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation 

medications) for both eyes 

Preoperative corneal astigmatism of 1.0 D or less 

Clear intraocular media other than cataract 

Availability, willingness, and sufficient cognitive awareness to comply 

with examination procedures 

Good candidate for multifocal lens, if the subject prefers multifocal lens 

implantation (subject desires spectacle independence and understands 

the trade-off of improved near vision to possible unwanted visual 

sensations – see also OptiVis Physician Brochure) 




XII. EXCLUSION CRITERIA 

Concurrent participation or participation during the last 30 days in any 

clinical trial 

Use of systemic or ocular medications that may affect vision (the use of 

any miotic agent is specifically contraindicated) 

Acute or chronic disease or illness that would increase the operative risk 

or confound the outcome(s) of the study (e.g., diabetes mellitus, 

immunocompromised, connective tissue disease, etc.) 

Uncontrolled systemic or ocular disease (for example: uncontrolled 

ocular hypertension or glaucomatous changes in the retina) 

History of ocular trauma or prior ocular surgery 

Amblyopia or strabismus 

Corneal abnormalities such as stromal, epithelial or endothelial 

dystrophies 

Intraocular inflammation or recurrent ocular inflammatory condition 

Known pathology that may affect visual acuity; particularly retinal 

changes that affect vision (macular degeneration, cystoid macular 

edema, proliferative diabetic retinopathy, etc.) 

Diagnosed degenerative visual disorders (e.g. macular degeneration, or 

other retinal disorders) that are predicted to cause future acuity losses to 

a level of 20/30 or worse 

Subjects who may be expected to require retinal laser treatment or other 

surgical intervention 

Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped 

pupils, or pupils that do not dilate at least 4.0 mm under 

mesopic/scotopic conditions) 

Capsule or zonule abnormalities that may affect postoperative IOL 

centration or tilt, including pseudoexfoliation, trauma, or surgical 

complications (e.g. zonular rupture, eccentric anterior capsulorhexis) 

Requiring an intraocular lens 25.0 diopters 

Contact lens usage within 6 months for PMMA contacts lenses, 1 month 

for gas permeable lenses or 1 week for extended-wear and daily-wear 

soft contact lenses. 




XIII. VISIT SCHEDULE 

The comparative study visit schedule for each subject will be as follows (*): 

Visit Eyes Evaluated Exam Visit Window 

1 Both Eyes Preoperative Exam Within 60 days 

prior to 1 st 

surgery 

2 First Eye Operative 1-60 days 

following preop 

3 First Eye Postop 1 (1week postoperative)* 7-14 days 

4 Second Eye Operative Within 1 month 

after 1 st eye 

surgery 

5 Second Eye Postop 1 (1week postop from 

2 nd implant) 

7-14 days 

6 Both Eyes Postop 2 (1 month postop from 

2 nd implant) 

30 days 

7 Both Eyes Postop 3 (3 month postop from 

2 nd implant) 

90 days 

8 Both Eyes Postop 4 (6 months postop from 180 days 

2 nd implant) 

* Postop 1 for the first eye is to be completed prior to surgery on the 

second eye. 

A. PREOPERATIVE 

No subject had been entered into the study who did not meet the 

inclusion/exclusion criteria for both eyes. 

The preoperative exam was completed within 60 days prior to surgery for 

the first eye. The preoperative visit included testing designed to establish 

the subject’s capability of achieving 20/30 Snellen or better distance vision 

after cataract extraction and IOL implantation. The surgeon had the option 

of using the Mentor Potential Acuity Meter (PAM), laser interferometer, 

McIntyre Pinhole, or his or her judgment to estimate the subject’s potential 

acuity. The method used to determine potential acuity was recorded. 

Preoperative refraction is required. Best-corrected distance visual acuity 

was measured and should be worse than 20/40 Snellen or worse than 

20/30 Snellen in the presence of glare with a Brightness Acuity Tester 

(BAT). Photopic pupil size was measured preoperatively as well. 

Intraocular pressure was measured preoperatively. The physician used 

the method of his or her choice provided the same method is used for all 

subjects at that site both preoperatively and postoperatively. The method 

used was recorded on the case report forms. 




Preoperative corneal astigmatism was 1.0 D or less as determined by 

keratometry or topography. No irregular astigmatism was present 

preoperatively. 

B. SUMMARY OF PREOPERATIVE PROCEDURES 

The preoperative clinical case report form required the following 

information for both eyes: 

• Lens preference and eye designation for first and second surgery 

• Subject demographic information 

• Potential visual acuity 

• Cataract type and density 

• Keratometry 

• Pupil size; photopic 

• Refraction 

• Uncorrected and best-corrected distance visual acuity using a 

standard Snellen chart (with BAT glare testing, if BCDVA 20/40 or 

better) 

• Intraocular pressure 

• Biomicroscopic slit lamp exam 

• Optical/Visual symptoms 

• Axial length 

• Targeted refraction 

• Power calculation formula and A-constant used 

C. OPERATIVE 

Cataract extractions were performed using the physician’s standard smallincision, 

phacoemulsification cataract extraction surgical technique. 

Lenses were folded for implantation and inserted through an incision 

ranging in size from 2.2 to 3.0 mm, as per the physician’s standard 

technique when using the implantation system. The incision type was 

based on the discretion of the physician. Wound closure was left to the 

surgeon’s discretion. Viscoelastic materials and preoperative and 

intraoperative medications are used as is customary for each physician. 

D. OPERATIVE REPORT 

The operative case report form required the following information: 

• Date of surgery 

• Operative eye 

• Lens serial number and power 

• Incision type, location, and size 




• Capsulorhexis size 

• Posterior Capsule polishing 

• Other surgical procedures 

• Surgical complications 

• Medications 

• Viscoelastic used 

• Implant instrumentation used 

• Lens placement 

• Type of closure 

• Difficulty of lens implantation 

E. POSTOPERATIVE 

Subjects underwent postoperative visits according to the visit schedule. 

For the early postoperative period examination (1 week), only the most 

recently operated eye was evaluated. Both eyes were evaluated at the 

same time for the 1 month, 3 month and 6 month exams (postoperative to 

implantation of the second eye). Refractions were adjusted when 

performing the postoperative vision tests. Refractions were adjusted for 

the test distance when necessary (e.g. by approximately 0.25 D to adjust 

a 4 meter (13 foot) test distance to optical infinity or vice-versa). 

Distance Visual Acuity Testing 

Distance visual acuity was measured using the ETDRS self-calibrating, 

retro-illuminated boxes at a distance of 4 meters (13 feet) with the 100% 

ETDRS acuity charts, or the surgeon’s preferred method. The following 

measurements were taken during the study: 

Test Illumination Type of Testing 

Best corrected distance Photopic Monocular 

visual acuity 

Binocular 

Uncorrected distance visual Photopic Monocular 

acuity 

Binocular 




Intermediate Visual Testing 

Intermediate visual acuity testing was performed using ETDRS near acuity 

cards and held at a fixed distance of 70 cm. The following measurements 

were taken during the study: 


Uncorrected intermediate Photopic Monocular 

visual acuity 

Binocular 

Distance-corrected Photopic Monocular 

intermediate visual acuity 

Binocular 

Near Visual Acuity Testing 

Near visual acuity testing was performed using ETDRS near acuity cards 

and were held at a fixed distance of 40 cm. The following measurements 

were taken during the study: 


Uncorrected near visual Photopic Monocular 

acuity 

Binocular 

Distance-corrected near Photopic Monocular 

visual acuity 

Binocular 

F. PUPIL SIZE 

Photopic pupil size was measured during the study. Pupil size was 

measured with a standard pupil gauge card, millimeter rule or pupilometer. 

G. OTHER EVALUATIONS 

A biomicroscopic slit lamp exam was performed at each postoperative visit 

to determine the presence or absence of lens decentration and tilt, status 

of the posterior capsule including striae and posterior capsule 

opacification. 

H. POSTOPERATIVE REPORTS 

Specific examinations were requested as follows, although not all were 

required at each visit: 

• Manifest Refraction 

• Distance Visual Acuities 

• Monocular and binocular uncorrected distance visual acuity under 


• Monocular and binocular best corrected distance visual acuity under 


• Intermediate Visual Acuities 

• Monocular and binocular uncorrected intermediate visual acuity using 

ETDRS near charts under photopic conditions at a fixed distance 




• Monocular and binocular distance-corrected intermediate visual acuity 

using ETDRS near charts under photopic conditions at a fixed distance 

• Near Visual Acuities 

• Monocular and binocular uncorrected near visual acuity using ETDRS 

near charts under photopic conditions at a fixed distance 

• Monocular and binocular distance-corrected near visual acuity using 

ETDRS near charts under photopic conditions at a fixed 

• Pupil size 

• Photopic conditions 

• Slit lamp examination for lens centration/tilt, clarity of capsule, striae 

ratings and general ocular status 

• Adverse events 

• Posterior capsulotomy performed 

XIV. PERFORMANCE CRITERIA 

Study sites were compared with respect to subject uncorrected and bestcorrected 

distance visual acuity (UCVA & BCVA), (b) uncorrected and distancecorrected 

intermediate visual acuity (UCIVA & DCIVA) at 70 cm, (c) uncorrected, 

distance-corrected near visual acuity (UCNVA &DCNVA) at 40 cm under 

photopic conditions, (d) subject satisfaction. 

All study data was collected on the appropriate CRFs and entered into a 

database by the Sponsor. Tables, descriptive statistics and comparative statistics 

were generated in order to assess the efficacy of the OptiVis MPDL as well as 

the endpoints as described in section V of this report. 

The Investigator carefully reviewed the CRFs and assured the accuracy and 

completeness of each CRF page. The Investigator signed and dated the 

Investigator Signature Page(s) to verify that all of the data entered in the CRFs 

are correct. 

Subject Data was excluded from the visual acuity report if bilateral implants were 

not performed. Data was also excluded if a comment was made by the Principle 

Investigator regarding the post-operative state of the subject that may have had 

an affect on the subject’s visual acuity performance at the time of any of the 

follow-up evaluations. 

Visual Acuity data was entered into the database as a Snellen result, e.g., 20/20, 

and later converted into the logMAR progression equivalent for statistical 

analysis. The mean and standard deviation (SD) was calculated for each time 

point interval, e.g., 1-month, 3-month, etc… to establish the average visual acuity 

for the subject population. Results were also calculated as a percentage of the 

total subject population for the given time point. 




Survey results were calculated as a percentage of the total subject population for 

the given time point. Survey answers from subjects who did not have bilateral 

implants were included in this report. 

XV. RESULTS 

A total of 108 eyes from male and female subjects that have been implanted with 

the OptiVis IOL at 2 international clinical sites were analyzed. 

EYES EVALUATED BY STUDY SITE AT 1-MONTH POST-OP 

Site 

Centro Microchirurgia 

Ambulatoriale srl 

PI N Eyes N Subjects 


20052 Monza 

Dr. Matteo Piovella 74 37 

Italy 

Cabinet 

d’Ophtalmologie 


44000 Nantes 

France 

Dr. Jean-Michel Bosc 34 17 

Total 108 54 

EYES EVALUATED BY STUDY SITE AT 3-MONTHS POST-OP 

Site 





20052 Monza 


Italy 

Cabinet 



44000 Nantes 

France 


Total 94 47 

EYES EVALUATED BY STUDY SITE AT 6-MONTHS POST-OP 

Site 





20052 Monza 


Italy 

Cabinet 



44000 Nantes 

France 


Total 88 44 




A. ONE-MONTH 

1 Month (108 Eyes) 

UCDVA BCDVA UCIVA DCIVA UCNVA DCNVA 

Mean 0.09 0.03 0.27 0.26 0.21 0.20 

St. Dev. 0.10 0.07 0.15 0.15 0.13 0.12 

logMAR 0.09 ± 0.10 0.03 ± 0.07 0.27 ± 0.15 0.26 ± 0.15 0.21 ± 0.13 0.20 ± 0.12 

Snellen 20/25 20/20 20/40 20/40 20/32 20/32 

One-month data included results from 108 eyes. The mean uncorrected 

distance visual acuity was 20/25 (0.09 ± 0.10 logMAR), and the mean bestcorrected 

distance visual acuity was 20/20 (0.03 ± 0.07 log MAR). At onemonth 

postoperative, the percentage of eyes that had a distance bestcorrected 

visual acuity of 20/32 or better at 99.1%. See table below. 

1 Month 

BCDVA 

20/16 or better 9.3% 

20/20 or better 81.5% 

20/25 or better 96.3% 

20/32 or better 99.1% 

The one-month mean uncorrected intermediate distance visual acuity was 

20/40 (0.27 ± 0.15 logMAR), and the mean distance-corrected intermediate 

visual acuity was 20/40 (0.26 ± 0.15 logMAR). At one-month postoperative, 

the percentage of eyes that had a distance-corrected intermediate visual 

acuity of 20/40 or better at 78.7%. See table below. 

1 Month 

DCIVA 

20/16 or better 3.7% 

20/20 or better 10.2% 

20/25 or better 26.9% 

20/32 or better 48.1% 

20/40 or better 78.7% 




The one-month mean uncorrected near visual acuity was 20/32 (0.21 ± 0.13 

logMAR), and the mean distance-corrected near visual acuity was 20/32 (0.20 

± 0.12 logMAR). At one-month postoperative, the percentage of eyes that had 

a distance-corrected near visual acuity or 20/40 or better at 90.7%. See table 

below. 

1 Month 

DCNVA 

20/20 or better 11.1% 

20/25 or better 35.2% 

20/32 or better 71.3% 

20/40 or better 90.7% 

B. THREE-MONTH 

3 Months (94 Eyes) 


Mean 0.06 0.02 0.26 0.25 0.21 0.19 

St. Dev. 0.10 0.05 0.15 0.13 0.12 0.11 

logMAR 0.06 ± 0.10 0.02 ± 0.05 0.26 ± 0.15 0.25 ± 0.13 0.21 ± 0.12 0.19 ± 0.11 

Snellen 20/25 20/20 20/40 20/40 20/32 20/32 

Three-month data included results from 94 eyes. The mean uncorrected 


distance visual acuity was 20/20 (0.02 ± 0.05 logMAR). At threemonths 


visual acuity of 20/32 or better at 100%. See table below. 

3 Months 

BCDVA 

20/16 or better 11.7% 

20/20 or better 84.0% 

20/25 or better 97.9% 

20/32 or better 100.0% 

The three-month mean uncorrected intermediate distance visual acuity was 


visual acuity was 20/40 (0.25 ± 0.13 logMAR). At one-month postoperative, 



3 Months 

DCIVA 

20/16 or better 4.3% 

20/20 or better 13.8% 

20/25 or better 27.7% 

20/32 or better 50.0% 

20/40 or better 73.4% 




The three-month mean uncorrected near visual acuity was 20/32 (0.21 ± 0.12 


± 0.11 logMAR). At three-months postoperative, the percentage of eyes that 

had a distance-corrected near visual acuity or 20/40 or better at 95.7%. See 

table below. 

3 Months 

DCNVA 

20/20 or better 16.0% 

20/25 or better 30.9% 

20/32 or better 72.3% 

20/40 or better 95.7% 

C. SIX-MONTH 

6 Months (88 Eyes) 


Mean 0.07 0.01 0.26 0.22 0.22 0.18 

St. Dev. 0.09 0.04 0.14 0.13 0.12 0.10 

logMAR 0.07 ± 0.09 0.01 ± 0.04 0.26 ± 0.14 0.22 ± 0.13 0.22 ± 0.12 0.18 ± 0.10 

Snellen 20/25 20/20 20/40 20/32 20/32 20/32 

Six-month data included results from 92 eyes. The mean uncorrected 


distance visual acuity was 20/20 (0.01 ± 0.04 logMAR). At sixmonths 


visual acuity of 20/32 or better at 100%. See table below. 

6 Months 

BCDVA 

20/10 or better 1.1% 

20/16 or better 11.4% 

20/20 or better 89.8% 

20/25 or better 97.7% 

20/32 or better 100.0% 

The six-month mean uncorrected intermediate distance visual acuity was 


visual acuity was 20/32 (0.22 ± 0.13 logMAR). At six-months postoperative, 






6 Months 

DCIVA 

20/16 or better 5.7% 

20/20 or better 22.7% 

20/25 or better 34.1% 

20/32 or better 53.4% 

20/40 or better 90.9% 

The six-month mean uncorrected near visual acuity was 20/32 (0.22 ± 0.12 


± 0.10 logMAR). At six-months postoperative, the percentage of eyes that had 

a distance-corrected near visual acuity or 20/40 or better at 95.5%. See table 

below. 

D. SUBJECT SATISFACTION 

6 Months 

DCNVA 

20/16 or better 2.3% 

20/20 or better 14.8% 

20/25 or better 33.0% 

20/32 or better 80.7% 

20/40 or better 95.5% 

Subject satisfaction surveys were administered to the subjects at 1, 3 and 6 

months postoperative. Subjects were asked a series of questions pertaining 

to their contentment with their every day lifestyles after their cataract lens 

replacement surgery. Questions focused primarily on the subject’s lifestyle 

without the use of spectacle/glasses. 

Six-month results from the survey showed that 88.9% of the subjects never 

wear glasses, while 11.1% sometime wear glasses. 

How often do you wear eye glasses? 

Always 0.0% 

Sometimes 11.1% 

Never 88.9% 

When asked how satisfied they were with their daytime vision without 

glasses, 64.6% responded that they were completely satisfied while 35.4% 

responded that they were mostly satisfied. 




How satisfied are you with your 

vision without glasses during the 

day? 

Not at all 0.0% 

A little 0.0% 

Moderately 0.0% 

Mostly 35.4% 

Completely 64.6% 

When asked about their satisfaction level with their vision at night without the 

use of glasses, 40.9% responded that they were completely satisfied, while 

59.1% responded that they were mostly and moderately satisfied. 

E. DATA REPORT 

Please see attachment XVII A. 

F. SERIAL NUMBERS 

Please see attachment XVII B. 

G. CONCLUSION 

How satisfied are you with your 

vision without glasses at night? 

Not at all 0.0% 

A little 0.0% 

Moderately 9.1% 

Mostly 50.0% 

Completely 40.9% 

The OptiVis Mulitfocal IOL has provided excellent visual acuity at distance, 

near, and intermediate. Additional, longer-term follow-up studies are planned. 

XVI. LITERATURE REVIEW 

Please see attachment XVII C. 

XVII. ATTACHMENTS 

A. DATA REPORT 




ONE-MONTH DATA 

Doctor 

Pt. 

Initials 

Interval UCDVA BCDVA UCNVA DCNVA UCIVA DCIVA 

Bosc BC 1 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc BC 1 month 0.10 0.10 0.00 0.00 0.00 0.00 

Bosc BJC 1 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc BJC 1 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc CMC 1 month 0.16 0.00 0.20 0.20 0.20 0.20 

Bosc CMC 1 month 0.16 0.00 0.00 0.00 0.30 0.30 

Bosc DAM 1 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc DAM 1 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc FJ 1 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc FJ 1 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc FM 1 month 0.10 0.00 0.00 0.00 0.20 0.20 

Bosc FM 1 month 0.10 0.00 0.00 0.00 0.20 0.20 

Bosc GM 1 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc GM 1 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc GM 1 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc GM 1 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc GML 1 month 0.10 0.00 0.10 0.20 0.10 0.20 

Bosc GML 1 month 0.10 0.00 0.10 0.20 0.10 0.20 

Bosc HL 1 month 0.50 0.10 0.10 0.10 -0.10 -0.10 

Bosc HL 1 month 0.10 0.00 0.00 0.00 -0.10 -0.10 

Bosc LG 1 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc LG 1 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc LJ 1 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc LJ 1 month 0.16 0.16 0.10 0.10 0.10 0.10 

Bosc LJ 1 month 0.20 0.10 0.10 0.10 0.20 0.20 

Bosc LJ 1 month 0.30 0.20 0.10 0.10 0.20 0.20 

Bosc ND 1 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc ND 1 month 0.10 0.00 0.10 0.20 0.10 0.20 

Bosc RH 1 month 0.10 0.00 0.00 0.00 -0.10 -0.10 

Bosc RH 1 month 0.10 0.00 0.00 0.00 -0.10 -0.10 

Bosc RY 1 month 0.50 0.50 0.10 0.10 0.10 0.10 

Bosc RY 1 month 0.50 0.10 0.10 0.10 0.10 0.10 

Bosc TM 1 month 0.10 0.00 0.10 0.10 0.00 0.00 

Bosc TM 1 month 0.10 0.00 0.10 0.10 0.00 0.00 

Piovella AA 1 month 0.00 0.00 0.30 0.30 0.30 0.30 


Piovella AR 1 month 0.00 -0.10 0.20 0.20 0.40 0.40 

Piovella AR 1 month 0.10 0.00 0.30 0.20 0.40 0.30 

Piovella AS 1 month 0.10 0.10 0.30 0.30 0.40 0.40 


Piovella BA 1 month 0.10 0.00 0.20 0.20 0.30 0.20 




Piovella BG 1 month 0.16 0.00 0.00 0.00 0.10 0.10 




Doctor 

Pt. 

Initials 


Piovella BG 1 month 0.00 0.00 0.20 0.20 0.40 0.40 

Piovella CB 1 month 0.10 0.00 0.30 0.20 0.20 0.30 

Piovella CB 1 month -0.10 -0.10 0.20 0.20 0.20 0.10 

Piovella CI 1 month 0.00 0.00 0.20 0.20 0.30 0.30 


Piovella CM 1 month 0.10 -0.10 0.30 0.20 0.30 0.20 

Piovella CM 1 month -0.10 -0.10 0.40 0.20 0.40 0.40 

Piovella CT 1 month 0.00 -0.10 0.20 0.30 0.30 0.30 

Piovella CT 1 month 0.10 0.00 0.30 0.30 0.40 0.20 

Piovella DCA 1 month 0.10 0.00 0.20 0.20 0.30 0.20 

Piovella DCA 1 month 0.00 -0.10 0.30 0.10 0.40 0.40 

Piovella DLC 1 month 0.10 0.00 0.30 0.40 0.40 0.40 


Piovella DPA 1 month 0.00 0.00 0.20 0.20 0.20 0.20 


Piovella FA 1 month 0.00 0.00 0.20 0.20 0.30 0.30 


Piovella FE 1 month 0.20 0.10 0.50 0.50 0.60 0.60 


Piovella GAC 1 month 0.00 0.00 0.20 0.20 0.30 0.30 

Piovella GAC 1 month 0.00 -0.10 0.20 0.20 0.30 0.30 

Piovella JF 1 month 0.16 0.00 0.50 0.50 0.30 0.30 

Piovella JF 1 month 0.00 0.00 0.30 0.20 0.70 0.60 

Piovella LI 1 month 0.10 0.00 0.30 0.20 0.40 0.40 


Piovella LV 1 month 0.00 0.00 0.30 0.30 0.30 0.30 


Piovella MA 1 month 0.10 0.00 0.40 0.30 0.40 0.40 


Piovella MG 1 month 0.00 0.00 0.00 0.00 0.00 0.00 




Piovella MP 1 month 0.00 0.00 0.20 0.10 0.40 0.40 


Piovella PC 1 month 0.00 0.00 0.30 0.30 0.20 0.20 


Piovella RA 1 month 0.10 0.00 0.40 0.40 0.40 0.40 

Piovella RA 1 month 0.00 -0.10 0.10 0.10 0.20 0.20 

Piovella RP 1 month 0.10 0.00 0.30 0.30 0.30 0.30 


Piovella SF 1 month 0.10 0.10 0.50 0.50 0.50 0.50 




Piovella SG 1 month 0.16 0.10 0.10 0.10 0.30 0.30 




Doctor 

Pt. 

Initials 




Piovella SP 1 month 0.10 0.00 0.40 0.40 0.50 0.50 


Piovella SR 1 month 0.00 0.00 0.30 0.30 0.30 0.30 


Piovella TA 1 month 0.00 0.00 0.40 0.40 0.50 0.50 


Piovella TA 1 month 0.00 -0.10 0.30 0.20 0.20 0.20 


Piovella TE 1 month 0.10 0.00 0.20 0.20 0.30 0.30 


Piovella TL 1 month 0.10 0.00 0.30 0.20 0.50 0.50 


Piovella VG 1 month 0.00 -0.10 0.30 0.20 0.20 0.20 

Piovella VG 1 month 0.10 0.00 0.30 0.20 0.30 0.30 

Piovella ZC 1 month 0.10 0.10 0.20 0.30 0.20 0.20 


Mean 0.09 0.03 0.21 0.20 0.27 0.26 

St. Dev 0.10 0.07 0.13 0.12 0.15 0.15 

THREE-MONTH DATA 

Doctor 

Pt. 

Initials 


Bosc BC 3 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc BC 3 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc BJC 3 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc BJC 3 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc CMC 3 month 0.16 0.00 0.20 0.20 0.00 0.00 

Bosc CMC 3 month 0.16 0.00 0.00 0.00 0.10 0.10 

Bosc DAM 3 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc DAM 3 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc FJ 3 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc FJ 3 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc FM 3 month 0.20 0.10 0.20 0.20 0.20 0.20 

Bosc FM 3 month 0.20 0.10 0.20 0.20 0.20 0.20 

Bosc GM 3 month 0.50 0.10 0.10 0.10 0.10 0.10 

Bosc GM 3 month 0.50 0.10 0.10 0.10 0.10 0.10 

Bosc GML 3 month 0.20 0.20 0.10 0.20 0.10 0.20 

Bosc GML 3 month 0.20 0.20 0.10 0.20 0.10 0.20 

Bosc LJ 3 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc LJ 3 month 0.00 0.00 0.10 0.10 0.10 0.10 

Bosc LJ 3 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc LJ 3 month 0.10 0.10 0.10 0.10 0.10 0.10 

Bosc ND 3 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc ND 3 month 0.00 0.00 0.00 0.00 0.00 0.00 




Doctor 

Pt. 

Initials 


Bosc RH 3 month 0.10 0.00 0.00 0.00 -0.10 -0.10 

Bosc RH 3 month 0.00 0.00 0.00 0.00 -0.10 -0.10 

Bosc TM 3 month 0.10 0.00 0.00 0.00 -0.10 -0.10 

Bosc TM 3 month 0.10 0.00 0.00 0.00 -0.10 -0.10 







Piovella BA 3 month 0.10 -0.10 0.20 0.20 0.30 0.30 








Piovella CT 3 month -0.10 -0.10 0.20 0.20 0.20 0.20 



Piovella DCA 3 month 0.00 -0.10 0.30 0.30 0.40 0.40 


Piovella DLC 3 month 0.00 -0.10 0.30 0.30 0.40 0.40 















Piovella MG 3 month 0.00 -0.10 0.30 0.30 0.40 0.30 




Piovella MP 3 month 0.00 -0.10 0.20 0.20 0.40 0.40 

Piovella MP 3 month 0.00 -0.10 0.30 0.30 0.40 0.40 






Doctor 

Pt. 

Initials 

















Piovella TA 3 month -0.10 -0.10 0.20 0.20 0.20 0.20 




Piovella TL 3 month 0.10 -0.10 0.20 0.20 0.40 0.40 



Piovella VML 3 month 0.10 0.10 0.50 0.30 0.60 0.40 




Mean 0.06 0.02 0.21 0.19 0.26 0.25 

St. Dev 0.10 0.05 0.12 0.11 0.15 0.13 

SIX-MONTH DATA 

Doctor 

Pt. 

Initials 


Bosc BC 6 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc BC 6 month 0.10 0.00 0.00 0.00 0.00 0.00 

Bosc BJC 6 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc BJC 6 month 0.00 0.00 0.00 0.00 0.00 0.00 

Bosc CMC 6 month 0.40 0.00 0.10 0.10 0.20 0.00 

Bosc CMC 6 month 0.16 0.00 0.10 0.10 0.20 0.00 

Bosc DAM 6 month 0.00 0.00 0.00 0.00 -0.10 -0.10 

Bosc DAM 6 month 0.00 0.00 0.00 0.00 -0.10 -0.10 

Bosc FJ 6 month 0.16 0.10 0.20 0.10 0.10 0.00 

Bosc FJ 6 month 0.16 0.10 0.20 0.10 0.10 0.00 

Bosc FM 6 month 0.16 0.00 0.20 0.10 0.10 0.10 

Bosc FM 6 month 0.30 0.00 0.20 0.10 0.10 0.10 

Bosc GE 6 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc GE 6 month 0.10 0.00 0.00 0.10 0.10 0.10 




Doctor 

Pt. 

Initials 


Bosc GML 6 month 0.16 0.16 0.10 0.10 0.00 0.00 

Bosc GML 6 month 0.10 0.00 0.10 0.10 0.00 0.00 

Bosc HL 6 month 0.16 0.00 0.10 0.00 -0.10 -0.10 

Bosc HL 6 month 0.16 0.00 0.00 0.00 -0.10 -0.10 

Bosc LG 6 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc LG 6 month 0.10 0.00 0.10 0.10 0.10 0.10 

Bosc LJ 6 month 0.10 0.10 0.00 0.00 -0.10 -0.10 

Bosc LJ 6 month 0.00 0.10 0.10 0.10 0.00 0.00 

Bosc ND 6 month 0.00 0.00 0.10 0.00 0.10 0.00 

Bosc ND 6 month 0.00 0.00 0.00 0.00 0.10 0.00 

Bosc TM 6 month 0.10 0.00 0.10 -0.10 0.30 0.00 

Bosc TM 6 month 0.10 0.00 0.10 -0.10 0.30 0.10 





Piovella AS 6 month 0.00 -0.10 0.30 0.30 0.40 0.40 

Piovella AS 6 month 0.00 -0.10 0.30 0.30 0.40 0.30 







Piovella CM 6 month 0.00 0.00 0.30 0.20 0.30 0.30 

Piovella CM 6 month 0.00 0.00 0.30 0.20 0.30 0.30 

Piovella CT 6 month -0.10 -0.10 0.20 0.20 0.20 0.20 







Piovella DPA 6 month -0.30 -0.30 0.30 0.20 0.30 0.20 
















Doctor 

Pt. 

Initials 






Piovella PC 6 month -0.30 0.00 0.30 0.20 0.20 0.10 













Piovella TA 6 month -0.10 -0.10 0.20 0.20 0.20 0.20 











Mean 0.07 0.01 0.22 0.18 0.26 0.22 

St. Dev 0.09 0.04 0.12 0.10 0.14 0.13 





B. SERIAL NUMBERS 


Subject 

# 



DR. PIOVELLA 

Subject 

Initials 

Op 

Eye 

Date of 

Implant 

1 Week 

Visit 

1 Month 

Visit 

3 Month 

Visit 

6 Month 

Visit 


Lens Serial 

Number 

01 NA 1 OS 18-May-09 25-May-09 18-Jun-09 8-Sep-09 28-Nov-09 09134-0001 

02 BG 2 OD 8-Jun-09 16-Jun-09 1-Jul-09 28-Sep-09 1-Feb-10 09152-0049 

03 MG OD 8-Jun-09 16-Jun-09 15-Jul-09 10-Sep-09 2-Dec-09 09139-0017 

04 ZC OS 8-Jun-09 6-Jun-09 8-Jul-09 29-Sep-09 2-Feb-10 09134-0008 

05 ZC OD 15-Jun-09 23-Jun-09 8-Jul-09 29-Sep-09 2-Feb-10 09152-0103 

06 TA OD 7-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09134-0002 

07 RA OD 16-Jul-09 23-Jul-09 1-Sep-09 18-Feb-10 13-May-10 09139-0023 

08 PC OD 16-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09152-0064 

09 LV OD 16-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09139-0018 

10 AA OD 16-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09152-0032 

11 LI OD 16-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09152-0001 

12 SF OS 16-Jul-09 23-Jul-09 1-Sep-09 1-Feb-10 18-May-10 09152-0065 

13 TA OS 9-Sep-09 17-Sep-09 14-Oct-09 1-Feb-10 18-May-10 09152-0105 

14 PC OS 9-Sep-09 17-Sep-09 19-Oct-09 1-Feb-10 18-May-10 09152-0073 

15 LV OS 9-Sep-09 17-Sep-09 14-Oct-09 1-Feb-10 18-May-10 09139-0022 

16 AA OS 9-Sep-09 17-Sep-09 14-Oct-09 1-Feb-10 18-May-10 09139-0021 

17 LI OS 9-Sep-09 17-Sep-09 14-Oct-09 1-Feb-10 18-May-10 09152-0006 

18 SF OD 9-Sep-09 17-Sep-09 14-Oct-09 1-Feb-10 18-May-10 09152-0040 

19 MG OD 9-Sep-09 17-Sep-09 10-Oct-09 12-Feb-10 13-May-10 09152-0070 

20 SR OS 9-Sep-09 17-Sep-09 12-Oct-09 12-Feb-10 13-May-10 09134-0018 

21 MG OS 18-Sep-09 26-Sep-09 19-Oct-09 12-Feb-10 13-May-10 09152-0075 

22 RP OS 18-Sep-09 26-Sep-09 20-Oct-09 15-Feb-10 13-May-10 09134-0020 

23 CT OS 18-Sep-09 26-Sep-09 20-Oct-09 15-Feb-10 13-May-10 09152-0107 

24 FC 3 OD 18-Sep-09 26-Sep-09 MISSED 6 6-May-10 11-Jun-10 09152-0129 

25 AR OS 18-Sep-09 26-Sep-09 19-Oct-09 15-Feb-10 13-May-10 09139-0020 

26 CB OD 18-Sep-09 26-Sep-09 20-Oct-09 15-Feb-10 13-May-10 09152-0047 

27 TL OD 18-Sep-09 26-Sep-09 30-Oct-09 15-Feb-10 13-May-10 09152-0007 

28 DLC OD 7-Oct-09 15-Oct-09 12-Nov-09 18-Feb-10 13-May-10 09139-0005 

29 BA OD 7-Oct-09 15-Oct-09 12-Nov-09 18-Feb-10 14-May-10 09134-0007 

30 DCA OD 7-Oct-09 15-Oct-09 17-Nov-09 15-Feb-10 14-May-10 09265-0078 

31 SR OD 7-Oct-09 15-Oct-09 30-Nov-09 12-Feb-10 13-May-10 09134-0019 

32 RP 32 7-Oct-09 15-Oct-09 16-Nov-09 15-Feb-10 13-May-10 09152-0087 

33 TL OS 7-Oct-09 15-Oct-09 16-Nov-09 15-Feb-10 13-May-10 09152-0020 

34 CB OS 7-Oct-09 15-Oct-09 16-Nov-09 15-Feb-10 13-May-10 09152-0051 

35 CT OD 7-Oct-09 15-Oct-09 16-Nov-09 15-Feb-10 13-May-10 09152-0071 

36 AR OD 7-Oct-09 15-Oct-09 16-Nov-09 15-Feb-10 13-May-10 09152-0036 

37 CI OS 5-Oct-09 12-Oct-09 9-Nov-09 18-Jan-10 30-Jun-10 09152-0072 

38 CI OD 12-Oct-09 19-Oct-09 9-Nov-09 18-Jan-10 30-Jun-10 09152-0056 

39 MG OD 12-Oct-09 20-Oct-09 10-Nov-09 19-Jan-10 16-Apr-10 09152-0024 

40 CM OD 5-Nov-09 12-Nov-09 10-Dec-09 MISSED 6 31-May-10 09177-0027 

41 VG OS 5-Nov-09 12-Nov-09 10-Dec-09 5-Mar-10 31-May-10 09152-0084 

1 Subject NA (ID 01) was not included in the visual acuity analysis because only 1 eye (OS) was implanted 

with the OptiVis lens, implant date 18May2009. 

2 Subject BG (ID 02) was not included in the visual acuity analysis because only 1 eye (OD) was implanted 

with the OptiVis lens, implant date 08Jun2009. 

3 Subject FC (ID 24) was not included in the visual acuity analysis due to a diagnosis of severe corneal 

edema.



Subject Subject Op Date of 1 Week 1 Month 3 Month 6 Month Lens Serial 

# Initials Eye Implant Visit Visit Visit Visit Number 

42 VML 4 OS 5-Nov-09 12-Nov-09 10-Dec-09 5-Mar-10 31-May-10 09152-0093 

43 MA OS 5-Nov-09 12-Nov-09 10-Dec-09 5-Mar-10 31-May-10 09152-0063 

44 TA OD 5-Nov-09 12-Nov-09 10-Dec-09 5-Mar-10 31-May-10 09152-0062 

45 BA OS 5-Nov-09 12-Nov-09 17-Dec-09 18-Feb-10 14-May-10 09226-0023 

46 DCA OS 5-Nov-09 12-Nov-09 17-Dec-09 15-Feb-10 14-May-10 09152-0074 

47 RA OS 5-Nov-09 12-Nov-09 17-Dec-09 18-Feb-10 13-May-10 09152-0045 

48 DLC OS 5-Nov-09 12-Nov-09 17-Dec-09 18-Feb-10 13-May-10 09139-0007 

49 DPA OD 3-Dec-09 10-Dec-09 25-Jan-10 24-Apr-10 11-Jun-10 09289-0201 

50 AS OD 3-Dec-09 10-Dec-09 25-Jan-10 24-Apr-10 11-Jun-10 09289-0129 

51 GAC OD 3-Dec-09 10-Dec-09 25-Jan-10 24-Apr-10 11-Jun-10 09152-0164 

52 FA OD 3-Dec-09 10-Dec-19 25-Jan-10 24-Apr-10 11-Jun-10 09226-0009 

53 MA OD 3-Dec-09 10-Dec-09 14-Jan-10 5-Mar-10 31-May-10 09289-0111 

54 VML OD 3-Dec-09 10-Dec-09 8-Jan-10 5-Mar-10 11-Jun-10 09152-0104 

55 TA OS 3-Dec-09 10-Dec-09 14-Jan-10 5-Mar-10 31-May-10 09152-0050 

56 VG OD 3-Dec-09 10-Dec-09 14-Jan-10 5-Mar-10 31-May-10 09152-0052 

57 CM OS 3-Dec-09 10-Dec-09 14-Jan-10 MISSED 6 31-May-10 09177-0028 

58 SF OD 9-Nov-09 17-Nov-09 9-Dec-09 9-Mar-10 17-May-10 09265-0019 

59 SG OD 16-Nov-09 23-Nov-09 17-Dec-09 25-Feb-10 MISSED 6 09152-0155 

60 SG OS 23-Nov-09 1-Dec-09 17-Dec-09 25-Feb-10 MISSED 6 09152-0122 

61 TE OS 23-Nov-09 30-Nov-09 11-Jan-10 16-Feb-10 18-May-10 09152-0189 

62 TE OD 30-Nov-09 3-Dec-09 11-Jan-10 16-Feb-10 18-May-10 09152-0190 

63 SMP OD 23-Nov-09 30-Nov-09 29-Dec-09 3-Feb-10 4-May-10 09152-0121 

64 SMP OS 30-Nov-09 10-Dec-09 29-Dec-09 3-Feb-10 4-May-10 09314-0004 

65 VF OD 23-Nov-09 1-Dec-09 21-Dec-09 MISSED 6 MISSED 6 09134-0021 

66 BA OD 30-Nov-09 9-Dec-09 21-Dec-09 16-Mar-10 MISSED 6 09152-0057 

67 BA OS 14-Dec-09 21-Dec-09 14-Jan-10 16-Mar-10 MISSED 6 09289-0125 

68 VF OS 8-Feb-10 15-Feb-10 10-Mar-10 MISSED 6 MISSED 6 09134-0017 

69 GAC OS 9-Feb-10 17-Feb-10 8-Mar-10 24-Apr-10 11-Jun-10 09134-0037 

70 AS OS 9-Feb-10 17-Feb-10 8-Mar-10 24-Apr-10 11-Jun-10 09289-0203 

71 DPA OS 9-Feb-10 17-Feb-10 8-Mar-10 24-Apr-10 11-Jun-10 09152-0053 

72 FA OS 9-Feb-10 17-Feb-10 8-Mar-10 24-Apr-10 11-Jun-10 09152-0046 

73 FC OS 9-Feb-10 17-Feb-10 8-Mar-10 6-May-10 11-Jun-10 09152-0140 

74 SP OS 1-Mar-10 9-Mar-10 30-Mar-10 17-Jun-10 MISSED 6 09152-0141 

75 FE OD 1-Mar-10 9-Mar-10 6-Apr-10 9-Jun-10 MISSED 6 09152-0106 

76 SP OD 8-Mar-10 16-Mar-10 30-Mar-10 17-Jun-10 MISSED 6 09314-0003 

77 FE OS 8-Mar-10 6-Apr-10 6-Apr-10 9-Jun-10 MISSED 6 09152-0094 

78 SF OS 19-Apr-10 28-Apr-10 17-May-10 MISSED 6 MISSED 6 09139-0024 

79 BG OD 31-May-10 9-Jun-10 30-Jun-10 MISSED 6 MISSED 6 09313-0377 

80 BGP OS 3-May-10 10-May-10 3-Jun-10 MISSED 6 MISSED 6 09152-0092 

Subject 

# 

DR. BOSC 

Subject 

Initials 

OpEye 

Date of 

Implant 

1 Week 

Visit 

1 Month 

Visit 

3 Month 

Visit 

6 Month 

Visit 


Lens Serial 

Number 

1A DP OD 5-Aug-09 MISSED 6 7-Sep-09 MISSED 6 MISSED 6 09134-0003 

1B DP OS 1-Oct-09 5-Aug-09 MISSED 6 7-Sep-09 MISSED 6 09152-0090 

2A LG OD 5-Aug-09 1-Oct-09 12-Oct-09 MISSED 6 MISSED 6 09152-0124 

4 Subject VML (ID 42) was unable to provide 1-month date due to a diagnosis of cystoid macular edema.



Subject 

# 

Subject 

Initials 

OpEye 

Date of 

Implant 

1 Week 

Visit 

1 Month 

Visit 

3 Month 

Visit 

6 Month 

Visit 

Lens Serial 

Number 

2B LG OS 12-Aug-10 5-Aug-09 5-Aug-09 10-Sep-09 MISSED 6 09152-0123 

3A GML OD 12-Aug-09 12-Aug-09 MISSED 6 10-Sep-09 MISSED 6 09139-0028 

3B GML OS 19-Aug-09 12-Aug-09 25-Aug-09 17-Sep-09 15-Dec-09 09152-0088 

4A ND OD 9-Sep-09 19-Aug-09 25-Aug-09 17-Sep-09 15-Dec-09 09152-0033 

4B ND OS 16-Sep-09 9-Sep-09 17-Sep-09 15-Oct-09 14-Jan-10 09152-0034 

5A BJC OS 9-Sep-09 16-Sep-09 24-Sep-09 15-Oct-09 14-Jan-10 09152-0060 

5B BJC OD 16-Sep-09 9-Sep-09 17-Sep-09 15-Oct-09 11-Jan-10 09152-0055 

6A GM OD 9-Sep-09 16-Sep-09 24-Sep-09 15-Oct-09 11-Jan-10 09152-0125 

6B GM OS 18-Sep-09 9-Sep-09 15-Sep-09 19-Oct-09 15-Jan-10 09152-0127 

7A RY OD 12-Oct-09 18-Sep-09 21-Sep-09 19-Oct-09 15-Jan-10 09152-0116 

7B RY OS 19-Oct-09 12-Oct-09 20-Oct-09 17-Nov-09 MISSED 6 09152-0114 

8A LJ OD 5-Oct-09 19-Oct-09 3-Nov-09 17-Nov-09 MISSED 6 09152-0058 

8B LJ OS 12-Oct-09 5-Oct-09 13-Oct-09 10-Nov-09 11-Feb-10 09226-0020 

9A JJ 5 OS 7-Oct-09 12-Oct-09 20-Oct-09 10-Nov-09 11-Feb-10 09134-0010 

10A FJ OD 8-Oct-09 7-Oct-09 9-Oct-09 MISSED 6 9-Feb-10 09226-0021 

10B FJ OS 15-Oct-09 8-Oct-09 16-Oct-09 17-Nov-09 15-Dec-09 09226-0008 

11A GE OD 16-Oct-09 15-Oct-09 MISSED 17-Nov-09 15-Dec-09 09177-0024 

11B GE OS 20-Nov-09 16-Oct-09 29-Oct-09 18-Nov-09 MISSED 6 09152-0022 

12A DAM OD 21-Oct-09 20-Nov-09 1-Dec-09 MISSED 6 MISSED 6 09152-0113 

12B DAM OS 4-Nov-09 21-Oct-09 29-Oct-09 3-Dec-09 25-Mar-10 09139-0026 

13A LJ OD 2-Nov-09 4-Nov-09 10-Nov-09 3-Dec-09 25-Mar-10 09226-0030 

13B LJ OS 5-Nov-09 2-Nov-09 9-Nov-09 27-Nov-09 12-Mar-10 09226-0032 

14A BC OD 16-Nov-09 5-Nov-09 13-Nov-09 27-Nov-09 12-Mar-10 09265-0027 

14B BC OS 23-Nov-09 16-Nov-09 24-Nov-09 15-Dec-09 15-Apr-10 09152-0061 

15A RP OD 18-Jan-10 23-Nov-09 1-Dec-09 15-Dec-09 15-Apr-10 09289-0220 

15B RP OS 25-Jan-10 18-Jan-10 1-Feb-10 MISSED 6 MISSED 6 09289-0253 

16A FM OD 11-Feb-10 25-Jan-10 1-Feb-10 9-Mar-10 27-May-10 09289-0219 

16B FM OS 18-Feb-10 11-Feb-10 22-Feb-10 9-Mar-10 27-May-10 09289-0252 

17A GM OD 10-Mar-10 18-Feb-10 1-Mar-10 9-Mar-10 27-May-10 09343-0053 

17B GM OS 17-Mar-10 10-Mar-10 18-Mar-10 15-Apr-10 MISSED 6 09226-0031 

18A TM OD 4-May-10 17-Mar-10 25-Mar-10 15-Apr-10 MISSED 6 09343-0054 

18B TM OS 11-May-10 4-May-10 11-May-10 27-May-10 3-Aug-10 09314-0008 

19A CMC OD 5-May-10 11-May-10 MISSED 6 27-May-10 3-Aug-10 09343-0039 

19B CMC OS 12-May-10 5-May-10 14-May-10 3-Jun-10 No Date 09314-0009 

20A HL OD 16-Jun-10 12-May-10 25-May-10 3-Jun-10 No Date 10111-0638 

20B HL OS 23-Jun-10 16-Jun-10 24-Jun-10 2-Aug-10 MISSED 6 10075-0212 

22A RH OS 16-Aug-10 23-Jun-10 1-Jul-10 2-Aug-10 MISSED 6 

10075-0114 

22A RH OD 30-Aug-10 16-Aug-10 24-Aug-10 21-Sep-10 16-Dec-10 10081-0008 

5 Subject JJ (ID 9A) was not included in the visual acuity analysis because only 1 eye (OS) had been 

implanted with the OptiVis lens, implant date 07Oct2009> 

6 MISSED= Patient did not show up for scheduled follow-up visit, therefore, data was not collected nor 

analyzed for the appropriate time point. 





C. LITERATURE REVIEW (SEE ATTACHED LITERATURE REVIEW)

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