Verteporfin photodynamic therapy for neovascular age-related ...

More documents

Recommendations

Info

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.
Page 5 and 6:
DOI: 10.3310/hta16060Health Technol
Page 12 and 13:
xExecutive summaryretreat on criter
Page 14 and 15:
xiiExecutive summaryof data, with i
Page 16 and 17:
2 Introductionon-going or new clini
Page 18 and 19:
4 Introductionof VPDT in routine cl
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
Page 34 and 35:
20 Key changes to the protocolThese
Page 36 and 37:
22 Key changes to the protocolCentr
Page 38 and 39:
24 Key changes to the protocolADVER
Page 40 and 41:
26 Key changes to the protocolPlan
Page 42 and 43:
28 Key changes to the protocolClass
Page 44 and 45:
30 Key changes to the protocolFor i
Page 46 and 47:
32 Key changes to the protocolIn ad
Page 48 and 49:
34 Key changes to the protocolsites
Page 52 and 53:
38 Results (1) - study cohortTABLE
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
46 Results (2) - objectives A, B, C
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77:
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
Page 91 and 92:
Page 93 and 94:
Page 95:
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
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
Page 140 and 141: 126 Appendix 114. References[1] Ref
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
Page 160 and 161: 146 Appendix 1Appendix 5:Protocol f
Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
Page 164 and 165: 150 Appendix 1• The patient shoul
Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
Page 168 and 169: 154 Appendix 18. It is customary to
Page 170 and 171: 156 Appendix 1Early or Transit Phas
Page 172 and 173: 158 Appendix 1
Page 174 and 175: 160 Appendix 1---------------------
Page 180 and 181: 166 Appendix 1Appendix 9:Site imple
Page 182 and 183: 168 Appendix 1Option 2 - units inte
Page 184 and 185: 170 Appendix 1Dos and Don’tsDosDo
Page 186 and 187: 172 Appendix 1Resource use question
Page 188 and 189: 174 Appendix 1Appendix 11: Recommen
Page 190 and 191: 176 Appendix 1ADVERSE REACTION AND
Page 192 and 193: 178 Appendix 1acute Trust; note tha
Page 194 and 195: 180 Appendix 1Ophthalmologistrespon
Page 197 and 198: DOI: 10.3310/hta16060Health Technol
Page 203: DOI: 10.3310/hta16060Health Technol
Page 206 and 207:
192 Appendix 3manufacturer’s pers
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 216:
FeedbackThe HTA programme and the a
show all

Verteporfin photodynamic therapy for neovascular age-related ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?