Open angle glaucoma Eye Diseases Other cataract
Conditions
Interventions
Patients are randomised to either 5-fluorouracil or beta-radiation as follows:
1. 5-fluorouracil is applied subconjunctivally for a period of 3 minutes at a concentration of 50 mg/ml prior to undertak
Sponsors
University College London (UCL) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent to inclusion and participation in trial 2. Characteristic glaucomatous changes in the optic disc. 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. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.8. 3. 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 4. An open angle on gonioscopy 5. Visually significant cataract 6. Aged greater than 20 years, either sex
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 (last menstrual period [LMP]) 12. No clinically significant cataract 13. Chronic use of topical or systemic steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure at 12 months post-operatively. Surgical success at twelve months is defined as a maximum intraocular pressure less than 16 mmHg as measured using Goldmann tonometry on no ocular hypotensive therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual function, assessed within or at the first year after surgery 2. Reintervention, assessed within or at the first year after surgery 3. Reintervention acceptance, assessed within or at the first year after surgery 4. Surgical complications, measured during surgery and within two weeks of surgery | — |
Countries
Tanzania
Outcome results
None listed