Primary Glaucoma Treatment Trial in Kenya and South Africa - SLT vs. Medication

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.

Participating centres are:

Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation Eye Centre, Kisii, Kenya

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: Kisii Eye Hospital Kisii Kenya; University of KwaZulu
• Treatments: Bimatoprost

Criteria

Inclusion Criteria:

• • Consent to inclusion and participation in trial.

• 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.

• 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.

• Adequate visualization of angle structures (i.e. clear media and cooperative patient)

• Black African patients

Exclusion Criteria:

• • Unwillingness to participate in the study

• Inability/unwillingness to give informed consent

• Unwillingness to accept randomisation

• Patient less than 20 years of age

• Anterior segment neovascularisation

• Past trauma to the eye or ocular adnexae

• Retinal or optic nerve neovascularisation

• Aphakia or pseudophakia

• 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).

• Anyone who is not Black African race