Verteporfin photodynamic therapy for neovascular age-related ...

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140 Appendix 1testing on vision test charts) than patients who received a dummytreatment. However, many of the treated patients also continuedto lose eyesight. The treatment is extremely expensive and maynot be of benefit to some patients. It is important that the resultsare monitored for several reasons. These include, knowing howmany people actually benefit from the treatment, how long thetreatment should continue, the optimum way it should beundertaken, how sight loss impacts on the person’s quality of lifeand whether PDT treatment makes a difference to this and howmuch the treatment actually costs. In the VPDT cohort study weare hoping to answer these questions.WILL BEING IN THE STUDY INVOLVE HAVING TO UNDERGOANY ADDITIONAL TESTS?Almost all the information required for the study is collected aspart of the normal examinations and tests that you will have toundergo before you can receive PDT treatment. These testsincluding having your sight tested in detail, and having dropsinserted into your eyes to dilate the pupil so that the retina can beexamined thoroughly. After these tests are completed your retinaspecialist will order a fluorescein angiogram, which involves usinga special camera to photograph the eye. The photographs aretaken through the dilated pupil. A nurse or doctor will place aneedle in a suitable vein in your forearm or the back of the handand inject a yellow dye called fluorescein. This dye enters thecirculation and photographs of the blood vessels of the eye aretaken. The entire procedure for the fluorescein angiogram willtake about 20 minutes. If these tests show that you have classicor predominantly classic CNV, you will then be offered PDT. Youmay be asked to provide some additional information about theimpact of your eye condition on your ability to function and theeconomic consequences of having sight loss. This involvesasking you to answer some questionnaires. However you do nothave to agree to answer these questionnaires. Your refusal to fillout the questionnaires will not jeopardise your treatment withPDT if you need it. Even if you initially give consent to filling outthe questionnaires, you can change your mind at any time.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6141WILL I SUFFER ANY SIDE EFFECTS?Visudyne will make your skin extremely light sensitive in thefirst 24 - 48 hours after injection. If you stay in bright light fortoo long, your can suffer a reaction which is like having a badsunburn. Therefore you will be asked to take precautionswhich will include the wearing of dark glasses to protect youreyes, keeping the skin of your arms and legs covered andpreferably staying indoors for about 48 hours.In some people the eye sight in the treated eye may be evenmore blurred than it was before treatment and this may last afew days. If the drug leaks out of the blood vessel during theinjection, you are likely to experience some pain where theinjection is given. In this case, there may be a rash and theskin covering the leak will need to be covered for several daysto protect it from light.A small number of patients have had back pain and have feltsick during the injection. These feelings went away once theinjection was stopped. In a few people, severe worsening ofeyesight after visudyne treatment has been noticed. This isbecause some of the normal blood vessels in the retina arealso accidentally shut down during treatment. Veryoccasionally, bleeding may occur inside the eye, eyesight maybecome abnormal or eye pain and redness may beexperienced. Some of these symptoms may also be due to theAMD itself. Some patients have had one or more of thefollowing other side effects, namely headaches, dizziness or adrop in blood pressure.Approximately 1 in a 100 people develop severe sight lossimmediately following PDT which may never recover. Theexact reason why this happens is unclear but it may be due tohaemorrhage from damaged blood vessels or damage to thenormal blood vessels of the retina. However people with CNVwho have not had any treatment whatsoever can also developsudden severe sight loss owing to haemorrhage from the CNV.Therefore it is very difficult to tell if the treatment itself had© 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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xiiExecutive summaryof data, with i
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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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22 Key changes to the protocolCentr
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24 Key changes to the protocolADVER
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26 Key changes to the protocolPlan
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28 Key changes to the protocolClass
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30 Key changes to the protocolFor i
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32 Key changes to the protocolIn ad
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34 Key changes to the protocolsites
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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70 Discussion of resultsOur analyse
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72 Discussion of resultsA further c
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74 Discussion of resultsVPDT. It is
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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
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 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
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
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Page 142 and 143: 128 Appendix 1Barnes RM, Gee L, Tay
Page 144 and 145: 130 Appendix 1Appendix 1: Classifyi
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
Page 152 and 153: 138 Appendix 1There are many differ
Page 156 and 157: 142 Appendix 1something to do with
Page 158 and 159: 144 Appendix 1College of Ophthalmol
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Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
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Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
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Page 192 and 193: 178 Appendix 1acute Trust; note tha
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192 Appendix 3manufacturer’s pers
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FeedbackThe HTA programme and the a
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