Document Detail


Visual outcomes in the subfoveal radiotherapy study: a randomized controlled trial of teletherapy for age-related macular degeneration.
MedLine Citation:
PMID:  12149056     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To determine whether teletherapy with 6-mV photons can reduce visual loss in patients with subfoveal choroidal neovascularization in age-related macular degeneration. DESIGN: A multicenter, single-masked, randomized controlled trial of 12 Gy of external beam radiation therapy delivered to the macula of an affected eye vs observation only. SETTING: Three United Kingdom-based hospital units. PARTICIPANTS: Patients with age-related macular degeneration, aged 60 years and older, who had subfoveal choroidal neovascularization and a visual acuity of 20/200 (logMAR 1.0) or better. METHODS: Two hundred three patients were randomly assigned to radiotherapy or observation. Treatment was undertaken at designated radiotherapy centers, and patients assigned to the treatment group received a total dosage of 12 Gy of 6-mV photons in 6 fractions. Follow-up was scheduled at 3, 6, 12, and 24 months. After excluding protocol violators, the data from 199 patients were analyzed. MAIN OUTCOME MEASURES: The primary outcome measure was mean loss of distance visual acuity in the study eye at 12 and 24 months. Other outcome variables analyzed were near visual acuity and contrast sensitivity. The proportions of patients losing 3 or more or 6 or more lines of distance and near acuity and 0.3 or more or 0.6 or more log units of contrast sensitivity at each follow-up were also analyzed. RESULTS: At all time points, mean distance visual acuity was better in the radiotherapy-treated group than in the control group, but the differences did not reach statistical significance. At 24 months, analysis of the proportions of patients with loss of 3 or more (moderate) (P =.08) or 6 or more (severe) (P =.29) lines of distance vision showed that fewer treated patients had severe losses, but there was no statistically significant difference between groups. For near visual acuity, although there was no evidence of treatment benefit at 12 and 24 months, a significant difference in favor of treatment was present at 6 months (P =.048). When analyzed by the proportions of patients losing 3 lines of contrast sensitivity, there was a significant difference in favor of treatment at 24 months (P =.02). No adverse retinal effects were observed during the study, but transient disturbance of the precorneal tear film was noted in treated patients. CONCLUSION: The results of the present trial do not support the routine clinical use of external beam radiation therapy in subjects with subfoveal choroidal neovascularization in age-related macular degeneration.
Authors:
P M Hart; U Chakravarthy; G Mackenzie; I H Chisholm; A C Bird; M R Stevenson; S L Owens; V Hall; R F Houston; D W McCulloch; N Plowman
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of ophthalmology     Volume:  120     ISSN:  0003-9950     ISO Abbreviation:  Arch. Ophthalmol.     Publication Date:  2002 Aug 
Date Detail:
Created Date:  2002-07-31     Completed Date:  2002-08-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7706534     Medline TA:  Arch Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1029-38     Citation Subset:  AIM; IM    
Affiliation:
Department of Ophthalmology, The Royal Victoria Hospital, Queen's University of Belfast, Northern Ireland.
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MeSH Terms
Descriptor/Qualifier:
Aged
Choroidal Neovascularization / etiology,  physiopathology,  radiotherapy*
Contrast Sensitivity / physiology
Dose Fractionation
Female
Fluorescein Angiography
Follow-Up Studies
Fovea Centralis / physiopathology,  radiation effects*
Humans
Macular Degeneration / complications,  physiopathology,  radiotherapy*
Male
Prospective Studies
Radioisotope Teletherapy*
Single-Blind Method
Treatment Outcome
Visual Acuity / physiology*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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