The evaluation of adjunctive beta-irradiation for trabeculectomy in South Africa: does it enhance operative success and reduce overall failure in glaucoma management?
| ISRCTN | ISRCTN62430622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62430622 |
| Secondary identifying numbers | 056045 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ian Murdoch
Scientific
Scientific
University College London
Department of Epidemiology & Internal Medicine
11 - 42 Bath Street
London
EC1V 9EL
United Kingdom
| Phone | +44 (0)20 7608 6896 |
|---|---|
| i.murdoch@ucl.ac.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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? |
| Study objectives | 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(s) | This study was approved by the research ethics committees of all included centres, along with the Institute of Ophthalmology. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 03/11/1999 |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/11/1999 |
| Date of final enrolment | 19/06/2002 |
Locations
Countries of recruitment
- England
- South Africa
- United Kingdom
Study participating centre
University College London
London
EC1V 9EL
United Kingdom
EC1V 9EL
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
11 - 42 Bath Street
London
EC1V 9EL
England
United Kingdom
| Website | http://www.ucl.ac.uk/ioo/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/11/2006 | Yes | No |
