Verteporfin photodynamic therapy for neovascular age-related ...

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148 Appendix 16.2 Subjective RefractionThe following refraction protocol is adapted from those used in previous landmark clinicaltrials. It was written to ensure standardisation of vision testing by technicians who often werenot optometrically trained. For the purposes of the VPDT Cohort Study it should be viewedas a guide when testing is being performed by optometrists. However non-optometrists areadvised to strictly follow the protocol.• Always start with chart R. This is the chart used for refraction and for recordingpresenting BDVA, which must be measured before carrying out the refraction andmeasuring monocular DVA (see 7 below).• At the initial/first visit, the patient’s spectacles for distance viewing (if worn) should bemeasured with a lensometer, and these measurements used as the beginningapproximate refraction.• Refractions may be performed with minus or plus cylinders.• If the patient does not wear spectacles for distance vision, retinoscopy orautorefraction may be used.• Ensure that the patient does not lean forward and is using only the eye being tested.• When no correction is needed, start with plano.• If correction is needed start with current spectacle correction, retinoscopy result orautorefractor result (i.e. appropriate sphere, appropriate cylinder in measured axis)• Check which line of the chart the subject is able to read6.2.1 Refining the spherical correction• Subject looks at lowest line that he/she can read confidently• Hold challenge lens in front of trial frame over eye to be tested (range between +0.37 and + 1.00 depending upon acuity) and ask if this makes the lowest line seenbetter, no difference or worse.• If subject indicates better or no difference increase the sphere power in the trial lensframe and repeat with a plus challenge lens.• If better by reading additional letters, again increase the sphere in the trial frame andrepeat these steps until there is no further improvement or a definite reduction innumber of letters read.• If no change in number of letters read repeat challenge with a plus sphere. If subjectindicates better increase sphere power, and if no different again increase spherepower. Repeat these steps until performance shows worsening and then stop• If subject indicates vision is worse offer a minus challenge lens. If patient reads betterthen change sphere power accordingly using an equivalent minus correction.• Repeat cycle until subject indicates definite worsening.6.2.2 Refining the axis of the cylinder• Ask the subject to view a letter 1 line above the smallest line they can read• Hold the + 0.5 Jackson’s cross cylinder in front of the trial frame straddling the axis ofthe cylinder and flip to each side. Ask the subject to indicate which is clearer orwhether they are equally clear.• Move axis in the direction of reduced blur if subject indicates reduced blur with a flip.• Repeat this until subject indicates equal blur on both sides of the flip6.2.3 Refining the power of the cylinder• Align the Jackson’s cross cylinder with the power meridian of the lens in the trialframe and flip to present either the + 0.50 or the – 0.50.• Ask the subject to indicate which is better, flip 1 or flip 2.• If no difference is indicated, stop here
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6149• Adjust the power accordingly if one of the flips is indicated as better.• If + 0.50 is indicated as better reduce the power of the sphere in the trial lens by –0.25 and repeat until no difference is indicated.• If – 0.50 is indicated as better, increase power of the sphere in the trial lens by +0.25and repeat until no difference is indicated.6.2.4 Final steps in refraction• As a final check, repeat a round of the steps used to get the spherical correction• The best correction for each eye is determined from the subjective refraction shouldbe entered in the Record of Subjective Refraction.7 Recording of VAThe logMAR chart was designed for the recording of vision as a log of the Minimum Angle ofResolution. This is identified as the lowest line on which 3 letters are read and is recorded ina Snellen notation. An adaptation of the testing method is simply to record the number ofletters read. Alternatively, acuities can be recorded in logMAR notation where each full lineread is recorded as 0.1 (0.0, 0.1, 0.2 …..1.0, etc.) and each letter as 0.02 (0.60, 0.62.0.64…etc.). For the VPDT Cohort study the number of letters read is the preferred recordingmethod but logMAR conversion is acceptable.Before carrying out a refraction or measuring MDVA according to this protocol, thepatient’s presenting logMAR BDVA must be measured. Record the patient’spresenting binocular logMAR acuity using chart R, with the patient wearing thedistance spectacles that they usually wear. Record the number of letters read on thelogMAR acuity form in the relevant box (and in the database). It is preferable tomeasure the BDVA at 4M, but measuring at 2M is acceptable.In the VPDT Cohort Study the main outcome variable is the visual acuity measured at1 metre. To speed up the process the test takes place in two parts with initial testingat 2 or 4 metres, depending on unit preference, followed by testing at 1 metre only ifinsufficient numbers are read at the initial test distance. (DPs must inform the DataManagement Centre whether they wish to test at 4M or 2M. Appropriate forms forrecording logMAR acuities at 2M or 4M will be provided to centres.)A full refraction protocol is encouraged at every clinic visit, but must be done at thescreening visit, the visit when a patient is first treated (0 months), and yearly (12, 24and 36 months). When this is not possible, it is acceptable to record logMAR acuitiesusing the trial lenses of the prescription most recently used for vision testing. AlllogMAR acuities must be recorded in accordance with the following steps.• If possible, carry out a refraction according to the protocol described above (see6), using chart R. If not possible, proceed as described below.• Each eye should be tested separately at a specified distance (or distances, ifinsufficient letters are seen at the longer viewing distance)• Make sure that the form used to record the logMAR acuities is appropriate for thetesting distance (this will be clearly marked on the VPDT Cohort Study approvedlogMAR acuity form)• Use chart 1 to test the RE and chart 2 to test the LE• Place the appropriate correction in the trial frame on the eye to be tested (seeabove) and ensure that the fellow eye is occluded properly.• Ask the patient to read steadily line by line.• The examiner can make reassuring comments but should not tell the patientwhether a letter is correctly or incorrectly identified.© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.
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38 Results (1) - study cohortTABLE
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66 Discussion of resultsStrengths a
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74 Discussion of resultsVPDT. It is
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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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88 References83. Margrain TH. Minim
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90 Appendix 1THE VERTEPORFIN PHOTOD
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92 Appendix 11. Overview of Manual
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94 Appendix 1And, if also collectin
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96 Appendix 1more patients in the v
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Page 124 and 125: 110 Appendix 1The Verteporfin Photo
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Page 130 and 131: 116 Appendix 1level of benefit from
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FeedbackThe HTA programme and the a
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