Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in Intraocular Pressure
研究概览
简要总结
This study evaluates whether combining cataract surgery (phacoemulsification) with incisional goniotomy effectively lowers intraocular pressure (IOP) and reduces the need for glaucoma medications in patients with coexisting cataract and glaucoma.
Conventional filtering surgeries, such as trabeculectomy, effectively reduce eye pressure but are often associated with bleb-related complications, hypotony, and intensive postoperative management. Goniotomy is an angle-based, conjunctival-sparing procedure that enhances natural aqueous outflow by incising the trabecular meshwork. When performed alongside phacoemulsification, cataract removal deepens the anterior chamber while goniotomy addresses outflow resistance without disrupting conjunctival tissue.
The main goal of this study is to compare the efficacy and safety profile of combined phacoemulsification and goniotomy between two distinct glaucoma phenotypes: primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG).
Participants will:
- Undergo standard clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with nasal incisional goniotomy under direct gonioscopic visualization.
- Complete postoperative follow-up examinations at Day 1, Week 1, and Months 1, 3, 6, 9, and 12.
- Be monitored for changes in intraocular pressure, total number of glaucoma medications required, visual acuity, and postoperative complications for a minimum duration of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years and older (no upper limit).
- •Diagnosis of uncontrolled or progressive primary open-angle glaucoma (POAG) or primary angle-closure glaucoma (PACG).
- •Presence of visually significant cataract requiring phacoemulsification.
- •Willingness and ability to complete the postoperative follow-up schedule of at least 6 months.
排除标准
- •Secondary glaucoma.
- •Prior incisional glaucoma surgery or selective laser trabeculoplasty (SLT) in the study eye.
- •Corneal opacity preventing adequate gonioscopic visualization of the angle.
- •Associated retinal disease or non-glaucomatous optic nerve disease.
- •Inability or unwillingness to adhere to the follow-up schedule.
研究组 & 干预措施
PACG Group (Phaco-Goniotomy)
Patients with uncontrolled or progressive primary angle-closure glaucoma (PACG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization.
干预措施: Combined Phacoemulsification and Goniotomy (Procedure)
POAG Group (Phaco-Goniotomy)
Patients with uncontrolled or progressive primary open-angle glaucoma (POAG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization.
干预措施: Combined Phacoemulsification and Goniotomy (Procedure)
结局指标
主要结局
Change in Intraocular Pressure
时间窗: Baseline and 6 months postoperatively
Intraocular pressure is measured in millimeters of mercury (mmHg) using Goldmann applanation tonometry. Values represent the change in IOP calculated as post-intervention IOP minus baseline IOP.
次要结局
未报告次要终点
研究者
Ahmed Abdelnaser Mohamed Abdelnaser
Resident of Ophthalmology
Assiut University