Lagos State University teaching Hospital Eye Institute
Ikeja, Lagos, Nigeria
Location status: Recruiting
NCT Number: NCT07310719
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
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Ikeja, Lagos, Nigeria
Location status: Recruiting
STUDY AREA The research will be conducted at the Glaucoma clinic, Department of Ophthalmology, Lagos State University Hospital, Lagos, Nigeria. The hospital is one of the three tertiary centers in the state, delivering high-level healthcare services to the inhabitants of Lagos State and its surrounding communities. The Eye department's team includes consultant ophthalmologists, ophthalmic resident doctors, optometrists, ophthalmic nurses, pharmacists, medical record officers, account officers, and health attendants. The glaucoma clinic has a weekly throughput of approximately twenty new glaucoma patients and offers a comprehensive range of services, including optical, medical management, laser therapy, and surgical interventions. Patients are referred to the clinic from various sources, including the hospital's general outpatient department, as well as general and private hospitals within and outside Lagos state. There are two glaucoma clinic days in a week, and a total of approximately eighty-five glaucoma patients are seen per week with a staff strength of about seven.
STUDY DESIGN This is an observer-masked, prospective, randomized controlled trial. STUDY DURATION The study will be conducted over twelve months and will include data collection, analysis, results, and the conclusion of the thesis.
SAMPLE SIZE Total sample size for the study will be 138, 69 eyes per intervention group For this clinical analysis, the unit of analysis will be the eye. The sample size of eyes will be the available number of eyes from the number of patients recruited to the study.
ETHICAL CONSIDERATION The study will be submitted for ethical review and approval to the Lagos State University Teaching Hospital (LASUTH) Ethics and Research Committee. Written informed consent will be obtained from each participant following a detailed explanation of the study's purpose and procedures. Participant data will be kept confidential and the research will adhere to the tenets of the Helsinki Declaration
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Selective laser trabeculoplasty is a laser based treatment that reduces intraocular pressure. it is a safe alternative to medical therapy and surgery.
Latanoprost is a prostaglandin analogue, a first-line ocular hypotensive medication because of it's high intraocular pressure lowering efficacy.
Time frame: 3 months
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
Contact information is provided by the study sponsor or research team.
Anne I. Abang-Obi, MBBS
CONTACT
Chidinma C. Onyejekwe, FMCOph
CONTACT
Lagos State Health Service Commission
Other
Selective Laser Trabeculoplasty Versus Latanoprost as First Line Treatments for Primary Open-angle Glaucoma and Ocular Hypertension: A Comparative Analysis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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