The evaluation of adjunctive beta-irradiation for trabeculectomy in South Africa: does it enhance operative success and reduce overall failure in glaucoma management?
- Conditions
- GlaucomaSurgeryTrabeculectomy
- Registration Number
- ISRCTN62430622
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method