Verteporfin photodynamic therapy for neovascular age-related ...

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102 Appendix 14. Study population4.1 Inclusion criteria for the reference population• All patients referred for assessment at a PDT clinic in a DP, whether eligible ornot, will form the reference population; there are no exclusion criteria for people inthe reference population. DPs should submit a full set of data at the screeningvisit for all ineligible patients seen in person at the PDT clinic; the angiogram usedfor decision making should be submitted, whether the angiogram was carried outby the DP or by a referring centre.• Patients with subfoveal CNV due to AMD or any other disorder are eligible forinclusion in the VPDT study.• As part of the assessment the ophthalmologist in charge of the patient will make adecision on eligibility for treatment (see below). The decision to proceed totreatment will be made in conjunction with the patient.• Patients may be of any ethnicity or either gender.4.2 Criteria for treatment eligibility• CNV must be wholly or predominantly classic (that is 50% or more of the entirelesion must be comprised of classic CNV)• Best corrected visual acuity in the eye being considered for treatment must beequal to or better than Snellen 6/60, approximately equivalent to seeing any letteron the line corresponding to logMAR 1.0, or >30 lettersAppendix 1 provides an algorithm to help the clinician to classify CNV lesions, inorder to determine eligibility for treatment.4.3 Exclusion criteria for treatment• Patients with minimally classic or occult CNV• History of liver disease or severe photosensitivity due to any cause• Previous history of adverse reaction to either fluorescein or verteporfin• Patients who are unable to attend for treatment and follow-up.4.4 Follow-up and re-treatmentPatients will undergo 3 monthly ophthalmological and angiographic examinations todetermine whether repeat therapy is needed. The decision to re-treat will be based on
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6103a range of clinical and angiographic evidence. Appendix 2 includes examples of flowcharts used for making re-treatment decisions. Re-treatment criteria were alsoconsidered by the Verteporfin Round Table [3].© 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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xExecutive summaryretreat on criter
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2 Introductionon-going or new clini
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20 Key changes to the protocolThese
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26 Key changes to the protocolPlan
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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
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Page 118 and 119: 104 Appendix 15. Recruitment to the
Page 120 and 121: 106 Appendix 16. Background data co
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 136 and 137: 122 Appendix 112. Data issues12.1 D
Page 138 and 139: 124 Appendix 113. Organisation13.1
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Page 142 and 143: 128 Appendix 1Barnes RM, Gee L, Tay
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170 Appendix 1Dos and Don’tsDosDo
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176 Appendix 1ADVERSE REACTION AND
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FeedbackThe HTA programme and the a
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