Verteporfin photodynamic therapy for neovascular age-related ...

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22 Key changes to the protocolCentre code _____ VPDT DATASHEET version 2.11. Patient detailsa. Named. Hospital numberf. PCTh. Addressb. DOB ___ / ___ / ___ c. Gender M / Fe. NHS numberg. Phone numberPostcode2. Referral Details – NEW PATIENT ONLY (all ‘screened’ patients, irrespective ofwhether subsequently treated or not)a. Primary care (optometrist/GP) referral date ___ / ___ / ____ (dd/mm/yy) tick if approximateb. Ophthalmologist referral date ___ / ___ / ____ (dd/mm/yy) tick if approximatec. Referring hosp: First PDT centre:d. Diagnosis at referral (tick one box only) e. Smoking history Suspected CNV Never Predominantly classic CNV Current: Number of years smoked yrs Classic CNV Ex-smoker: Number of years smoked yrs Other Yrs/mths since last smoked yrs mthsf . Other health-related informationg. ImagingY / N Cardiovascular disease None OCT onlyY / N Use of statins ICG only BothY / N Family historyh. Consultant name: i. Consent: Full Partial Noj. Duration of symptomsk. VA at referral (Snellen)l. Number of previoustreatments for CNV(enter 0 if none)m. Cataract surgery (inc date)R weeks LR ____ / ________ / ____ LR laser photocoagulation LR PDT LR Intravenous drug injection LR PHA /ECC /NONE ___ /___/ ___ ___/ ___/ ___ PHA / ECC / NONE L3. Visit details (every visit)a. Date ___ / ___ / ___ b. Type of visit: Interim Scheduledc. Number of missed appoints since last visit Reason4. Assessment (every visit)a. Binocular logMAR VAb. Mths since first treatedc. LogMAR VA RL refracted this visitd. Contrast sensitivityR (1.5, 3, 4.5, 6, 9, 12, 15, 18, etc.) LRe. Date of VA test: this visit = 1 week ago > 1 week ago, ___/ ___/ ___f. Angiogram type: film digital SLOg. Date of angiogram: this visit = 1 week ago > 1 week ago, ___/ ___/ ___Page 1LFIGURE 3 Paper data collection forms recommended by the data management centre.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6235. Eye statusTick ONE status only (and related options) foreach eye on each visitRIGHT EYELEFT EYEa.b.c. No CNV If no CNV and VA0.4 logMAR),please indicate reason for reduced VA: AMD Amblyopia Other Ineligible Please indicate main reason(s) for beingineligible, and related options:i. Vision below minimum standard Delay (weeks)Reasons for delayii. Ineligible because of lesion characteristics Minimally classic with occult Occult / no classic Lesion too large Lesion >50% blood Lesion inactive No SRF No blood No exudates Lesion fibrosed Stable vision iv. Other (specify below) Observed Reason for observation: No recent drop in VA Borderline lesion charact’cs 50% haemorrhage Bilateral CNV, treat next visit Other d. Treated at this visit e.iii. Previously treated but not at this visit8. Adverse effects of treatmentAdverse event since last visit: Y NAdverse reaction during this treatment: Y NIf yes to either, FILL IN an adverse events form6. Lesion characteristicsOnly required for treated eye at the time of theFIRST treatmentRIGHT EYELEFT EYEa. Aetiology (tick one item only) AMD AMD recurrence after laser Pathological myopia Juxtapapillary Angioid streak Idiopathic PIC/POHS Uveitis RAP IPCV Other (specify) b. AMD characteristics (tick one only) Classic / no occult Predominantly classic Minimally classic with no occult Occult / no classic Location of lesion (tick one only): Subfoveal Juxtafoveal 7. Features of treated eyea. Required for ALL VISITSb.& c. Only required if treated at this visita.Additional features (tick all that apply) Symptomatic drop in VA Angiographic leakage Subretinal fluid (any) Subretinal fluid (at centre) Cystoid macular oedema Blood Fibrosis1-24%, 25-49%, 50-74%, >75% RPE tear Chorioretinal anastomosis b. |__|__|__|__| GLDµm |__|__|__|__|c.Treatment protocol deviation Drug dosage Infusion rate Infusion interruption Delay in light application Light exposure/laser failure Other Next scheduled visit: ______ weeks/monthsOphthalmologist responsiblefor tx decisionsSignature:Page 2FIGURE 3 Paper data collection forms recommended by the data management centre. (continued)© 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.
Page 5 and 6: DOI: 10.3310/hta16060Health Technol
Page 12 and 13: xExecutive summaryretreat on criter
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Page 80 and 81: 66 Discussion of resultsStrengths a
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72 Discussion of resultsA further c
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74 Discussion of resultsVPDT. It is
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DOI: 10.3310/hta16060Health Technol
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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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96 Appendix 1more patients in the v
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98 Appendix 12.4 Limitations of the
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100 Appendix 1Box 2 Key advantages
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102 Appendix 14. Study population4.
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104 Appendix 15. Recruitment to the
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106 Appendix 16. Background data co
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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112 Appendix 1• Additional clinic
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114 Appendix 18. Recording adverse
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116 Appendix 1level of benefit from
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118 Appendix 1• comparison of num
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120 Appendix 110.6 Sub-group analys
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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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126 Appendix 114. References[1] Ref
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128 Appendix 1Barnes RM, Gee L, Tay
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130 Appendix 1Appendix 1: Classifyi
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132 Appendix 1Liverpool re-treatmen
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134 Appendix 1Service StructurePlea
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136 Appendix 1Has your photographer
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138 Appendix 1There are many differ
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140 Appendix 1testing on vision tes
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142 Appendix 1something to do with
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144 Appendix 1College of Ophthalmol
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146 Appendix 1Appendix 5:Protocol f
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148 Appendix 16.2 Subjective Refrac
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150 Appendix 1• The patient shoul
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152 Appendix 1Appendix 6:Protocol f
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154 Appendix 18. It is customary to
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156 Appendix 1Early or Transit Phas
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158 Appendix 1
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160 Appendix 1---------------------
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166 Appendix 1Appendix 9:Site imple
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168 Appendix 1Option 2 - units inte
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170 Appendix 1Dos and Don’tsDosDo
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172 Appendix 1Resource use question
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174 Appendix 1Appendix 11: Recommen
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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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