Glaucoma Surgery Trabeculectomy
Conditions
Interventions
African patients with established primary open angle glaucoma requiring trabeculectomy are recruited in three participating centres in South Africa. Following randomisation, patients undergo primary t
Sponsors
University College London (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual assessment 2. Re-intervention rate 3. Surgical complications | — |
Countries
South Africa
Outcome results
None listed