Verteporfin photodynamic therapy for neovascular age-related ...

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146 Appendix 1Appendix 5:Protocol for logMAR visual acuity assessment andrefractionStandardising visual acuity testing is the key to obtaining repeatable and reliablemeasurements. The procedure described below has been developed and refined from anumber of previously conducted clinical trials including the MPS studies, SFRADS andTAP/VIP.• Acuity testing should preferably be undertaken in dedicated facilities using chartswith standardised and uniform lighting.• The testing distances should be accurately marked out and the procedure followedshould be identical from one patient to the next and when the patient returns forsubsequent visits.• While equipment and light bulbs may be replaced as required every attempt must bemade to keep conditions as unchanged and as standardised as possible.1 ETDRS LogMAR Visual Acuity Charts• There are a number of ETDRS charts. For the purposes of the cohort study onlyCharts 1 and 2 and Chart R are needed.• Chart R is used for refraction, and for recording presenting BDVA (see 7 below).• After refraction is complete Charts 1 and 2 are used for testing the right and left eyerespectively.• Each line has 5 uniformly sized and spaced letters which decrease progressively insize from the top most line.LogMAR charts were developed and popularised by Bailey and Lovie and hence they aresometimes referred to as Bailey Lovie Charts. The visual angle is largest with the largestletters. The advantage of these charts is that there is a geometric progression of the visualangle with a doubling or a halving with every 3 line change. Therefore calculation of thevisual angle is very simple and allowances are made for the testing distance.• The charts may be standardised for testing at any distance, provided the appropriateconversions are clearly understood.• Changing the testing distance simply extends the range of acuity the chart can test.• Thus, for example, when used at a distance of 4M the acuity range is -0.3 logMAR to1.0.• By moving the chart to 2M, the range becomes 0.0 logMAR to 1.3.• When testing is undertaken at 1M, acuities as poor as 1.6 can be assessed.• Although standardised for the 4M distance, the chart can be easily used at 2M or 1M.• In order to obtain an acuity, when the chart has been used at 2M or 1M the examinersimply adds 15 letters or 0 letters (for 2M and 1M respectively) to the number ofletters read at the testing distance. (DPs already familiar with recording logMARacuities in logMAR units may use this format instead of letters, but must inform theData Management Centre that they wish to do so.)• Details of how the results of the tests should be recorded and scored are providedbelow (see 7 and 8). Duplicate forms for recording logMAR acuities will be suppliedto DPs.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 61472 Retroilluminated Visual Acuity Box• The illuminated box can be mounted on a wall or be used free standing.• The box should be placed so that the top of the third row of letters (0.8 logMAR at 4Metres testing distance) is 49 + 2 inches (124.5 + 5.1cm) from the floor.3 Ambient lighting• The room lights should preferably be turned off during the monocular visual acuitytest.• Retro-illumination within the box itself provides the appropriate level of illumination toundertake the test and should also allow the examiner to record the test resultswithout any additional lighting.4 Visual Acuity Lanes• A distance of 2 meters (78.7 inches) is required between the patient’s eyes and thevisual acuity chart for the 2 metre test, and a distance of exactly 1 meter (39.37inches) is required for the 1 metre test.• Wall-mounted box: In addition to the 4 meter lane, 17.78 cm (7 inches) must beallowed for the depth of the box plus space for the patient. If space is insufficient, thetest may be undertaken at any specified distance as long as this is taken into accountduring the recording of information.• Stand-mounted box: In addition to the 4 meter lane, 33.02cm (13 inches) must beallowed for the stand’s casters plus space for the patient.5 Marking the distance• The distances are measured from the lateral canthus of the eye of the patient, seatedcomfortably in a chair with his or her back firmly placed against the chair back, to thecentre of the second (left eye) or fourth letter (right eye) of the third line of the chart.The horizontal distance must be measured individually for each examination. 1 or 2metre sticks are ideal for this purpose.6 Refraction• All tests of visual function should be performed by a visual acuity examiner who hasbeen appropriately trained.6.1 EquipmentThe equipment required for refraction is:• Retroilluminated ETDRS chart set.• Trial lens frames• Trial lens set, with positive or negative cylinder lenses.• +0.37 and –0.37 spherical lenses. (+ and -0.50 are adequate if 0.37 are notavailable)• Jackson cross-cylinders of 0.25, 0.5, and 1.00 dioptres.• Pinhole occluder.Ideally full aperture lenses and the appropriate wire trial frame should be used toimprove the patient’s ability to eccentrically fixate during the test. However for thecohort study reduced aperture lenses will be acceptable if a full aperture set cannoteasily be obtained.© 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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46 Results (2) - objectives A, B, C
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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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Page 116 and 117: 102 Appendix 14. Study population4.
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Page 122 and 123: 108 Appendix 1Table 1: Schedule of
Page 124 and 125: 110 Appendix 1The Verteporfin Photo
Page 126 and 127: 112 Appendix 1• Additional clinic
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Page 130 and 131: 116 Appendix 1level of benefit from
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Page 138 and 139: 124 Appendix 113. Organisation13.1
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Page 192 and 193: 178 Appendix 1acute Trust; note tha
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FeedbackThe HTA programme and the a
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