Comparison of Phaco-Trabeculectomy Versus Combined Manual Small Incision Cataract Surgery with Trabeculectomy in Patients with Coexisting Cataract and Glaucoma At ECWA Eye Hospital, Kano, Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP)
研究概览
简要总结
The goal of this interventional study is to compare the outcomes of two surgical techniques, Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, in patients with coexisting cataract and glaucoma at ECWA Eye Hospital, Kano, Nigeria. The study aims to evaluate which technique offers better intraocular pressure (IOP) control, visual acuity improvement, and complication rates postoperatively.
The main questions the study seeks to answer are:
Does Phaco-Trabeculectomy provide superior IOP control compared to MSICS-Trabeculectomy in patients with coexisting cataract and glaucoma? Which technique is associated with fewer postoperative complications? How do the visual outcomes compare between the two techniques? Participants will be randomly assigned to undergo one of the two surgical techniques based on a predefined protocol. Data will be collected on intraoperative and postoperative parameters, including IOP, visual acuity, and the incidence of complications, with follow-ups extending over a 12-month period.
This study aims to provide evidence to guide clinicians in selecting the most effective and safe surgical approach for managing patients with cataract and glaucoma in resource-limited settings.
详细描述
Background and Rationale Cataract and glaucoma are two of the leading causes of preventable blindness globally, presenting significant public health challenges, particularly in resource-limited settings such as Nigeria. The coexistence of cataract and glaucoma complicates surgical management, as cataract surgery alone may improve visual acuity but is insufficient to achieve long-term control of intraocular pressure (IOP) in glaucoma patients.
Combined surgical procedures, such as Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, have been adopted to address these dual ocular conditions in a single intervention. However, evidence comparing the efficacy, safety, and long-term outcomes of these two approaches remains limited, particularly in Sub-Saharan Africa. This study seeks to bridge this critical gap in clinical evidence by generating region-specific data to optimize surgical decision-making for patients with coexisting cataract and glaucoma.
ECWA Eye Hospital, Kano, a tertiary eye care center in Nigeria renowned for its excellence in ophthalmology, provides the ideal setting for conducting this interventional study.
Study Objectives
This study aims to:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥18 years.
- •Patients diagnosed with coexisting cataracts and primary open-angle glaucoma.
- •Patients who have provided informed consent to participate in the study.
排除标准
- •Patients with angle-closure glaucoma.
- •Patients with secondary glaucoma or glaucoma-associated ocular or systemic anomalies.
- •Patients with a history of ocular surgeries, such as trabeculectomy, cataract surgery, or other glaucoma surgeries.
- •Patients with corneal or anterior segment diseases that could impede detailed examination (e.g., scleritis, bullous keratopathy, corneal scarring, corneal degenerations, or uveitis).
- •Patients with posterior segment diseases affecting visual interpretation (e.g., diabetic retinopathy, hypertensive retinopathy, high axial myopia, retinal detachment, vitreous hemorrhage, macular degeneration, central retinal vein occlusion, or sickle cell retinopathy).
- •Patients unwilling to provide voluntary informed consent or those who chose to withdraw from the study at any point.
- •Patients with only one functional eye.
结局指标
主要结局
Change in Intraocular Pressure (IOP)
时间窗: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery. To determine the relative effectiveness of the two surgical techniques in managing glaucoma-related elevated IOP.
The primary outcome measure is the change in intraocular pressure (IOP) from baseline to 12 months postoperatively. IOP will be measured using the Goldmann Applanation Tonometer, the gold standard for IOP measurement. Measurements will be recorded in millimeters of mercury (mmHg). The change in intraocular pressure (IOP) will reflect the effectiveness of the surgical intervention in controlling IOP over time. Lower IOP values within the normal range (10-21 mmHg) indicate successful pressure regulation and better surgical outcomes, reducing the risk of glaucoma progression. Conversely, persistently elevated IOP values may suggest surgical failure The changes in IOP will be compared between the Phaco-Trabeculectomy and MSICS-Trabeculectomy groups to assess the efficacy of each surgical technique in controlling intraocular pressure over the study duration.
次要结局
- Best-Corrected Visual Acuity (BCVA)(Baseline, Month 1, Month 3, Month 6, and Month 12 post-surgery)
- Postoperative Complications(Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.)
- Bleb Function(Month 1, Month 3, Month 6, and Month 12 post-surgery)
研究者
Emeka John Dingwoke
Director
UNESCO International Centre for Biotechnology, Nigeria