Selective Laser Trabeculoplasty Versus Latanoprost as First Line Treatments for Primary Open-angle Glaucoma and Ocular Hypertension: A Comparative Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Percentage intraocular pressure reduction from baseline
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage intraocular pressure reduction from baseline
时间窗: 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
次要结局
未报告次要终点
研究者
Anne Abang-Obi
Principal Investigator
Lagos State Health Service Commission