Verteporfin photodynamic therapy for neovascular age-related ...

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94 Appendix 1And, if also collecting the extended dataset:(h) Contrast sensitivity (p.25)(i) Quality of Life (p.26, p.29)(j) Resource use questionnaire (p. 27, p.30)At the first and subsequent visits, collect the following data for all treated patients:(k) Refractive error, based on a protocol refraction, at least every 12mths (p. 23)(l) Monocular LogMar VA collected at least every 3mths (p.21 and Table 1)(m) Binocular LogMar VA collected every 3mths (p. 21 and Table 1)(n) Stereo colour photography and angiography every 3mths, if treated at theprevious visit, otherwise six monthly (p. 22)(o) Treatment details on all visits when treatment is given (p.26)(p) Adverse events or reactions (p.28)And, if also collecting the extended dataset:(q) Contrast sensitivity every 6 months (p.22)(r) Quality of life every 6 months (p. 22)(s) Resource use questionnaire every 6 months (p. 22)(t) Adverse reactions and events (p28)Raw MDVA data should be collected on to the duplicate forms provided by the DMC.The ‘flimsy’ copies of these forms must be collected and returned periodically to theDMC.The data collected should be entered into the database provided. Ideally, thedatabase will be installed on the hospital’s local area network, allowing different staffto access the database simultaneously and to enter data as a patient progressesthrough his or her visit. Otherwise, DPs can use, or adapt, the data collection sheet(Appendix11) and enter data at a later time.The DMC will provide a data report to DPs, summarising the data submitted andlisting items of missing or suspect data. DPs must respond to these queries:1. providing data for missing items, if they are available, or confirming that missingdata are not recoverable, and2. correcting suspect data or confirming the original data are correct.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6952. Introduction2.1 Verteporfin photodynamic therapy (PDT) for the treatment of choroidalneovascularisation (CNV) of the eyeChoroidal neovascularisation (CNV) is the hallmark of the condition known asexudative age-related macular degeneration (AMD) of the eye. The untreated naturalhistory of CNV is one of relentless vision loss culminating in central visual impairmentof varying severity. This loss interferes with daily tasks such as reading, driving,watching television and recognising peoples’ faces and frequently results in loss ofindependent living.When CNV is subfoveal (that is, when CNV is under the centre of the fovea, the partof the retina that allows people to see fine detail), it is not amenable to thermal laserphotocoagulation, a form of therapy that has been the mainstay of management formany years. None of the treatments tested in recent years have been shown toimprove vision once it is lost, nor have there been treatments that consistentlyprevent additional decline in vision from the time of their application.Because the visual impairment caused by vision loss from exudative AMD is sosevere, it is now accepted that treatments which are only partly effective maynevertheless yield important visual, quality of life and economic benefits. Recently atreatment called verteporfin photodynamic therapy (PDT) has been shown toresult in a better outcome when compared with the natural history of CNV patientswho did not receive PDT. In the randomised controlled clinical trial the "Treatment ofAge-related macular degeneration by Photodynamic therapy (TAP) study", eyes withCNV exposed to laser irradiation following systemic infusion of the drug verteporfinwere more likely to have maintained visual function when compared with patients withsimilar CNV who received placebo followed by similar irradiation [1]. The treatmentworks because the drug verteporfin is internalised by the vascular endothelium. Lightactivation of the drug results in the release of free radicals that damage endotheliumand adjacent tissues and cells. By targeting a low energy laser into the region of theCNV, the endothelium of the aberrant blood vessels may be selectively irradiated,causing focal damage to the vessel wall and closure of the vessels comprising theCNV.2.2 NICE Guidance on Verteporfin PDTVerteporfin PDT was referred in 2000 for appraisal by the National Institute of ClinicalExcellence (NICE) [2], which reviewed available evidence. In the TAP trial, 15%© 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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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 110 and 111: 96 Appendix 1more patients in the v
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FeedbackThe HTA programme and the a
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