About this trial
The goal of this clinical trial is to compare the short-term efficacy and safety of selective laser trabeculoplasty (SLT) to 0.005% latanoprost eye drops in lowering intraocular pressure (IOP) as primary therapy in treatment-naïve patients diagnosed as early to moderate primary open-angle glaucoma(POAG) or ocular hypertension (OHT) in the Lagos State University Teaching Hospital, Ikeja. The main questions it aims to answer are:
1. Will Selective Laser Trabeculoplasty be an equally effective treatment option compared with 0.005% Latanoprost eyedrops in reducing Intraocular Pressure when used alone as first-line therapy in Nigerian patients with POAG and OHT? 2. Will Selective Laser Trabeculoplasty record a similar safety profile compared with 0.005% Latanoprost when used independently as a primary therapy? 3. How will the quality of life of patients who undergo Selective Laser Trabeculoplasty treatment compare with patients on 0.005% Latanoprost eyedrops?
Participants will be randomized to one of the two intervention groups. Group A(latanoprost group) will use 0.005% latanoprost eye drops every night at 2100hours(9.00pm) west African Time for 3 months. intraocular pressures will be monitored at intervals for a period of 3 months.
Group B(SLT group) will have Laser treatment administered as a one-off treatment. intraocular pressures will be monitored at intervals for a period of 3 months.
A record of side effects will be documented at each follow up visit
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18years and above.
Patients newly diagnosed as Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
Patients with elevated IOP greater than 21mmHg (average of 3 measurements taken on 3 different clinic visits).
Patients categorized as early or moderate glaucoma POAG (cup -disc ratio 0.5 to 0.7, visual field analysis MD - 6dB to -12dB and disc damage likelihood score (DDLS) 5 to 7) on funduscopy, Optical coherence tomography, and fundus photograph
Disqualifiers
A prior medical, surgical, or laser treatment for glaucoma
Patients diagnosed with primary congenital glaucoma or secondary glaucoma
Advanced glaucoma (CDR greater than 0.8, visual field analysis MD more than -12dB and DDLS stage 8 and above)
Patients with cloudy cornea or corneal opacity that would impair the view of the anterior chamber angles, fundus, or give false IOP readings
Trial design
Parallel
Treatments tested in this trial
Selective laser trabeculoplasty
Procedure/SurgerySelective laser trabeculoplasty is a laser based treatment that reduces intraocular pressure. it is a safe alternative to medical therapy and surgery.
Latanoprost (0.005%)
Other interventionLatanoprost is a prostaglandin analogue, a first-line ocular hypotensive medication because of it's high intraocular pressure lowering efficacy.
Treatment groups
Trial outcomes
Primary outcomes
Percentage intraocular pressure reduction from baseline
To compare the percentage reduction in IOP from baseline using SLT and 0.005% Latanoprost eye drops, each used independently as primary therapy over 3 months
Sponsors and contacts
Click on the lead sponsor to view all of their trials.