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

Официальное название

Selective Laser Trabeculoplasty Versus Latanoprost as First Line Treatments for Primary Open-angle Glaucoma and Ocular Hypertension: A Comparative Analysis

Обзор

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

Подробное описание

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

Вмешательства

• Процедура Selective laser trabeculoplasty
  Selective laser trabeculoplasty is a laser based treatment that reduces intraocular pressure. it is a safe alternative to medical therapy and surgery.
• Другое Latanoprost (0.005%)
  Latanoprost is a prostaglandin analogue, a first-line ocular hypotensive medication because of it's high intraocular pressure lowering efficacy.

Первичные конечные точки

• Percentage intraocular pressure reduction from baseline [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Nigeria · 1 центр

• Lagos State University teaching Hospital Eye Institute — Ikeja

Идентификаторы

NCT: NCT07310719 · LagosSHSC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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