- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310719
A Comparative Study of Intraocular Pressure Control Using Selective Laser Trabeculoplasty and Latanoprost as Initial Treatments for Primary Open Angle Glaucoma and Ocular Hypertension in Lagos State University Teaching Hospital
Selective Laser Trabeculoplasty Versus Latanoprost as First Line Treatments for Primary Open-angle Glaucoma and Ocular Hypertension: A Comparative Analysis
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:
- 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?
- Will Selective Laser Trabeculoplasty record a similar safety profile compared with 0.005% Latanoprost when used independently as a primary therapy?
- 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne I. Abang-Obi, MBBS
- Phone Number: +234 7061339223
- Email: iyeundiandeye@gmail.com
Study Contact Backup
- Name: Chidinma C. Onyejekwe, FMCOph
- Phone Number: +234 7060645714
Study Locations
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Lagos
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Ikeja, Lagos, Nigeria
- Recruiting
- Lagos State University teaching Hospital Eye Institute
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Contact:
- LASUTH Department of Ophthalmology
- Phone Number: 018980537
- Email: lasuthophthalmology@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Patients who agree to participate in the study after informed consent.
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Latanoprost 0.005%
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.
|
Latanoprost is a prostaglandin analogue, a first-line ocular hypotensive medication because of it's high intraocular pressure lowering efficacy.
|
|
Experimental: Selective laser trabeculoplasty
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
|
Selective laser trabeculoplasty is a laser based treatment that reduces intraocular pressure.
it is a safe alternative to medical therapy and surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage intraocular pressure reduction from baseline
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
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Prof B. Adekoya, FWACS, MD, Lagos State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LagosSHSC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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