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ISRCTN
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ISRCTN62430622
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ClinicalTrials.gov identifier
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Public title
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The evaluation of adjunctive beta-irradiation for trabeculectomy in South Africa: does it enhance operative success and reduce overall failure in glaucoma management?
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Scientific title
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Acronym
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N/A
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Serial number at source
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056045
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Study hypothesis
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To determine the feasibility of adjunctive beta-irradiation for trabeculectomy in an African setting. To determine the efficacy of adjunctive beta irradiation for trabeculectomy in African glaucoma in South Africa. To establish the pattern of attendance after primary trabeculectomy in an African setting and compliance with subsequent health interventions.
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Lay summary
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Ethics approval
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This study was approved by the research ethics committees of all included centres, along with the Institute of Ophthalmology.
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Study design
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A randomised prospective double blind controlled surgical trial of trabeculectomy with either peri-operative Beta irradiation or placebo augmentation.
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Countries of recruitment
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South Africa
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Disease/condition/study domain
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Glaucoma
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Participants - inclusion criteria
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1. Consent to inclusion and participation in trial
2. Characteristic glaucomatous changes in the optic disc
3. The presence of a focal or diffuse area of optic disc rim loss, so that the neuroretinal rim tissue in any quadrant is less than 5% of the disc diameter in that meridian
4. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.8
5. A measured intraocular pressure greater than or equal to 21 mmHg on at least one visit before the time of listing for surgery as measured by Goldmann applanation tonometry
6. An open angle on gonioscopy
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Participants - exclusion criteria
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1. Unwillingness to participate in the study
2. Anterior segment neovascularisation
3. Past trauma to the eye or ocular adnexae
4. Retinal or optic nerve neovascularisation
5. Aphakia or pseudophakia
6. Previous ocular surgery
7. Uveitis
8. Inability/unwillingness to give informed consent
9. Unwillingness to accept randomisation
10. Patient less than 20 years of age
11. Pregnancy or female of childbearing age who may be pregnant at time of treatment (LMP)
12. Clinically significant cataract
13. Chronic use of topical or systemic steroids
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Anticipated start date
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03/11/1999
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Anticipated end date
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31/01/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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320 - recruitment ends on the 19th June 2002
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Interventions
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African patients with established primary open angle glaucoma requiring trabeculectomy are recruited in three participating centres in South Africa. Following randomisation, patients undergo primary trabeculectomy with either exposure to 1000 cGy of Beta irradiation at the conclusion of surgery with a Strontium-90 containing delivery device, or a placebo exposure with an apparently identical device. Intraocular pressure is measured at regular intervals for at least 12 months.
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Primary outcome measure(s)
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Intraocular pressure at 12 months.
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Secondary outcome measure(s)
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1. Visual assessment
2. Re-intervention rate
3. Surgical complications
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 056045)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17023435
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Contact name
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Mr
Ian
Murdoch
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Address
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University College London
Department of Epidemiology & Internal Medicine
11 - 42 Bath Street
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City/town
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London
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Zip/Postcode
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EC1V 9EL
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Country
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United Kingdom
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Tel
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+44 (0)20 7608 6896
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Fax
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+44 (0)20 7250 3207
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Email
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i.murdoch@ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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11 - 42 Bath Street
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City/town
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London
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Zip/Postcode
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EC1V 9EL
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Country
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United Kingdom
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Sponsor website:
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http://www.ucl.ac.uk/ioo/
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Date applied
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22/07/2005
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Last edited
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07/03/2008
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Date ISRCTN assigned
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22/07/2005
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