Primary open-angle glaucoma Eye Diseases Primary open-angle glaucoma
Conditions
Interventions
After informed consent all patients undergo a standardised examination to establish baseline ocular function and findings. All patients receive counselling in glaucoma, the disease, what it means and
Sponsors
University College London
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 0.6 3. A measured intraocular pressure greater than or equal to 21 mmHg and less than or equal to 30mmHg on at least one visit before the time of entry into the study as measured by Goldmann applanation tonometry 4. Adequate visualization of angle structures (i.e. clear media and cooperative patient) 5. Black African patients
Exclusion criteria
Exclusion criteria: 1. Unwillingness to participate in the study 2. Inability/unwillingness to give informed consent 3. Unwillingness to accept randomisation 4. Patient less than 20 years of age 5. Anterior segment neovascularisation 6. Past trauma to the eye or ocular adnexae 7. Retinal or optic nerve neovascularisation 8. Aphakia or pseudophakia 9. Previous ocular surgery Evidence of ocular disease other than glaucoma that might affect the measurements of IOP, assessment of visual function, visual field testing would likely require cataract surgery within 12 months of randomization on systemic medications known to IOP (e.g. steroids) Pregnancy or female of childbearing age who may be pregnant at time of treatment (LMP). 10. Anyone who is not Black African race
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure reduction at one year. A reduction of 30% or more at one year is complete success and a reduction of 15-29% is partial success. In addition the proportion with an IOP less than 21, less than 17 and less than 14mmHg will be assessed as measured using Goldmann tonometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual function assessed as change in logMAR acuity 2. Progression of lens opacity assessed as change in LOCS III score 3. Reintervention rate- number experiencing reintervention during first year post commencement of therapy 4. Reintervention acceptance – number accepting reintervention during first year post commencement of therapy 5. Compliance – this is being assessed by weighing bottles prior to issuance and on return to the pharmacy for receipt of the next round of therapy (the difference in weight represents the number of drops administered from the bottle and will be compared to the number of doses that should have been taken during the period 6. Compliance via a questionnaire to both patients and clinician 7. Complications – number of adverse events during the first year of therapy | — |
Countries
Kenya, South Africa
Outcome results
None listed