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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:
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latanoprost 0.005% | Active Comparator | Latanoprost is an ocular hypotensive prostaglandin F2-alpha isopropyl ester prodrug that lowers IOP by increasing aqueous humour outflow through the uveoscleral pathway. Evidence from experimental and clinical trials suggests that Prostaglandin analogs are first-line agents as medical therapy for glaucoma because of the higher IOP-lowering effect, lower systemic side effects, and once daily dosing compared with other classes of drugs. Participants in this group will be required to instill latanoprost in both eyes daily in the evenings. |
|
| Selective laser trabeculoplasty | Experimental | Selective laser trabeculoplasty is a non-invasive, laser-based treatment that targets specific cells in the trabecular meshwork (TM) to improve aqueous humor outflow, thereby reducing intraocular pressure in patients with glaucoma or ocular hypertension. The selective nature of SLT reduces collateral tissue damage, making it a more advantageous option compared to other laser treatments, as it preserves surrounding tissue while effectively targeting the trabecular meshwork |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective laser trabeculoplasty | Procedure | Selective laser trabeculoplasty is a laser based treatment that reduces intraocular pressure. it is a safe alternative to medical therapy and surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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
Patients with media opacity, such as cataracts, vitreous haze, or vitreous hemorrhage that prevents examination of the posterior segment.
Patients who have undergone previous ocular surgeries (cataract surgery, trabeculectomy).
Patients with a history of ocular trauma or uveitis
Pregnant and lactating women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne I. Abang-Obi, MBBS | Contact | +234 7061339223 | iyeundiandeye@gmail.com | |
| Chidinma C. Onyejekwe, FMCOph | Contact | +234 7060645714 |
| Name | Affiliation | Role |
|---|---|---|
| Prof B. Adekoya, FWACS, MD | Lagos State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lagos State University teaching Hospital Eye Institute | Recruiting | Ikeja | Lagos | Nigeria |
Study protocol and study results
Requests for data can be submitted 9 months after article is published and data will be accessible for up to 3 years.
Access to Individual Participant Data (IPD) may be requested by researchers carrying out Independent Scientific research after a research proposal, Statistical Analysis Plan (SAP) and Data Sharing Agreement (DSA) are reviewed, approved and signed.
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| Latanoprost (0.005%) | Other | Latanoprost is a prostaglandin analogue, a first-line ocular hypotensive medication because of it's high intraocular pressure lowering efficacy. |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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