Verteporfin photodynamic therapy for neovascular age-related ...

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108 Appendix 1Table 1: Schedule of visits and tests for the VPDT cohort studyActivity ScreeningVisitMonth0Month3Month6Month9Month12Month15Month18Month21Month24Month36Minimum dataset:Informed consent XClinical history XRefraction a X X X X XBDVA & MDVAX X X X X* X X* X X* X Xmeasurement bOphthalmic Exam XStereo colour photography X X X X X* X* X* X* X* X* X*and angiography cdExtended data set:Contrast sensitivity test(Pelli-Robson)X X X X X XQuality of life & resourceuse questionnairesX X X X X X
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6109Notes for Table 1The screening / baseline visit and ‘month 0’ may be the same visit if a patient is treated atthe screening visit. Three monthly clinical visits, with distance visual acuity (BDVA andMDVA) checks, are mandatory up to 6 months after the first PDT treatment in all treatedpatients. Three monthly visits are also required in all patients continuing to receivetreatment. In patients who do not continue to receive treatment, we require 6 monthlyassessments, e.g. at months 12, 18, 24 if no treatment is given after month 6. After twoyears, we would like a follow-up visit at 3 years, if this falls within the duration of the study.Given that the scheduling of visits after 6 months depends on whether or not a patient istreated, some later visits (with asterisks) cannot be specified definitively.abcdProtocol refraction is encouraged at every visit, but must be carried out at the screeningvisit, the first treatment visit (month 0) and yearly (see Appendix 5, section 6).Presenting BDVA and best corrected MDVA measurements must be recorded at everyclinic visit (see Appendix 5, section 7); MDVA must be recorded using the formssupplied by the DMC (or a similar form showing the number of letters read on each line)and duplicate copies returned to the DMC.Stereo colour photography and angiography to be performed at month 0 and at everyvisit until the treated eye has been shown to be free of leakage on two occasions or untiltreatment has been stopped for clinical reasons. Photography and angiography aremandatory at treatment-related visits.In years 2 and 3, stereo colour photography and angiography is required on at least onevisit, but timing is not critical if the angiography is not treatment-related.© 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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DOI: 10.3310/hta16060Health Technol
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xExecutive summaryretreat on criter
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2 Introductionon-going or new clini
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4 Introductionof VPDT in routine cl
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20 Key changes to the protocolThese
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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Page 80 and 81: 66 Discussion of resultsStrengths a
Page 82 and 83: 68 Discussion of resultsThe VPDT st
Page 84 and 85: 70 Discussion of resultsOur analyse
Page 86 and 87: 72 Discussion of resultsA further c
Page 88 and 89: 74 Discussion of resultsVPDT. It is
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Page 98 and 99: 84 References16. Stelmack J. Qualit
Page 100 and 101: 86 References49. Guymer RH, Chiu AW
Page 102 and 103: 88 References83. Margrain TH. Minim
Page 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
Page 106 and 107: 92 Appendix 11. Overview of Manual
Page 108 and 109: 94 Appendix 1And, if also collectin
Page 110 and 111: 96 Appendix 1more patients in the v
Page 112 and 113: 98 Appendix 12.4 Limitations of the
Page 114 and 115: 100 Appendix 1Box 2 Key advantages
Page 116 and 117: 102 Appendix 14. Study population4.
Page 118 and 119: 104 Appendix 15. Recruitment to the
Page 120 and 121: 106 Appendix 16. Background data co
Page 124 and 125: 110 Appendix 1The Verteporfin Photo
Page 126 and 127: 112 Appendix 1• Additional clinic
Page 128 and 129: 114 Appendix 18. Recording adverse
Page 130 and 131: 116 Appendix 1level of benefit from
Page 132 and 133: 118 Appendix 1• comparison of num
Page 134 and 135: 120 Appendix 110.6 Sub-group analys
Page 136 and 137: 122 Appendix 112. Data issues12.1 D
Page 138 and 139: 124 Appendix 113. Organisation13.1
Page 140 and 141: 126 Appendix 114. References[1] Ref
Page 142 and 143: 128 Appendix 1Barnes RM, Gee L, Tay
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Page 146 and 147: 132 Appendix 1Liverpool re-treatmen
Page 148 and 149: 134 Appendix 1Service StructurePlea
Page 150 and 151: 136 Appendix 1Has your photographer
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Page 156 and 157: 142 Appendix 1something to do with
Page 158 and 159: 144 Appendix 1College of Ophthalmol
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166 Appendix 1Appendix 9:Site imple
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176 Appendix 1ADVERSE REACTION AND
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178 Appendix 1acute Trust; note tha
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180 Appendix 1Ophthalmologistrespon
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192 Appendix 3manufacturer’s pers
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FeedbackThe HTA programme and the a
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