Verteporfin photodynamic therapy for neovascular age-related ...

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.