Extract

Background and study aims Glaucoma is an eye condition which develops when a fluid inside the eye (called the aqueous humour) cannot drain properly, causing pressure to build up that can result in damage to the optic nerve and nerve fibres from the retina. It often affects both eyes, generally with one being more affected than the other, and, over time, it can lead to a partial or complete loss of sight. Primary open angle glaucoma (POAG) is the chronic, slowly developing form of the condition . There is currently a debate regarding what is the best first-line (first choice) therapy for POAG for African patients. Most African practitioners advocate trabeculectomy surgery (where a small hole is created to allow the excess fluid to drain from the eye). However, they are much more likely to treat the condition with drugs because, amongst other reasons, their patients won’t accept surgery. In the developed world, a range of first-line therapies including elective laser trabeculoplasty (SLT), have been advocated. SLT is a treatment where a laser beam is applied to the drainage channels of the eyes, which helps to unblock them and allow the aqueous humour to flow through them better, reducing the pressure. The purpose of this study is to compare a drug therapy (prostaglandin analogue) with SLT for the treatment of primary open angle glaucoma in an African population. Who can participate? African patients with established or newly diagnosed primary open angle glaucoma or patients with POAG currently on single drug therapy (excluding prostaglandin analogues) and elevated pressure in the eye (intraocular pressure). What does the study involve? Patients are randomly allocated into one of two groups. Those in group 1 are treated with SLT. Those in group 2 are provided with prostaglandin analogue with instructions for use and prescription to obtain supplies of the drug. Intraocular pressure is then measured at regular intervals for at least 12 months. Any side effects, complications or reoccurrence of high intraocular pressure are treated as appropriate for the duration of the study. What are the possible benefits and risks of participating? The benefits of taking part in the study include the encouragement and assistance to attend for follow-up for this chronic disease. In an African environment attendance for repeat review is infrequent hence management will be improved for those taking part in the study. There are no additional risks from taking part in the study. Where is the study run from? 1. Inkosi Albert Luthuli Central Hospital, Durban (South Africa) 2. Innovation Eye Centre, Kisii Eye Hospital (Kenya) When is the study starting and how long is it expected to run for? February 2014 to November 2018 Who is funding the study? International Glaucoma Association (UK) Who is the main contact? Mr Ian Murdoch [email protected]

Inclusion criteria

• Primary open-angle glaucoma

Links

• isrctn
• ictrp