Contact information
Type
Scientific
Primary contact
Mr Ian Murdoch
ORCID ID
Contact details
University College London
Department of Epidemiology & Internal Medicine
11 - 42 Bath Street
London
EC1V 9EL
United Kingdom
+44 (0)20 7608 6896
i.murdoch@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
056045
Study information
Scientific title
The evaluation of adjunctive beta-irradiation for trabeculectomy in South Africa: does it enhance operative success and reduce overall failure in glaucoma management?
Acronym
Study hypothesis
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.
Ethics approval
This study was approved by the research ethics committees of all included centres, along with the Institute of Ophthalmology.
Study design
Randomised prospective double-blind controlled surgical trial of trabeculectomy with either peri-operative Beta irradiation or placebo augmentation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Glaucoma
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Peri-operative Beta irradiation
Primary outcome measure
Intraocular pressure at 12 months.
Secondary outcome measures
1. Visual assessment
2. Re-intervention rate
3. Surgical complications
Overall trial start date
03/11/1999
Overall trial end date
31/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
320
Participant exclusion criteria
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
Recruitment start date
03/11/1999
Recruitment end date
19/06/2002
Locations
Countries of recruitment
South Africa
Trial participating centre
University College London
London
EC1V 9EL
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
11 - 42 Bath Street
London
EC1V 9EL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17023435
Publication citations
-
Results
Kirwan JF, Cousens S, Venter L, Cook C, Stulting A, Roux P, Murdoch I, Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial., BMJ, 2006, 333, 7575, 942, doi: 10.1136/bmj.38971.395301.7C.