Safety and Efficacy of Subscleral Trabeculectomy Combined With an Inverted T-Shaped Deep Sclerectomy for the Treatment of Primary Congenital Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP)
研究概览
简要总结
Primary congenital glaucoma (PCG) is a vision-threatening disorder of childhood characterized by elevated intraocular pressure (IOP) resulting from developmental abnormalities of the anterior chamber angle. Early surgical intervention is the standard treatment to preserve visual function and prevent progressive optic nerve damage.
This retrospective interventional case series evaluated the safety and efficacy of subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification) in children with PCG. Medical records of patients who underwent surgery between January 2022 and June 2025 at Benha University Hospital were reviewed. The primary outcome was reduction in intraocular pressure. Secondary outcomes included surgical success rates, reduction in antiglaucoma medication use, changes in corneal clarity and optic nerve status, postoperative complications, and the need for additional glaucoma surgery following a minimum follow-up of 12 months.
详细描述
Primary congenital glaucoma (PCG) is a rare developmental glaucoma caused by trabeculodysgenesis, leading to impaired aqueous humor outflow, elevated intraocular pressure (IOP), corneal enlargement and edema, optic nerve damage, and irreversible visual loss if untreated. Surgical management remains the primary treatment because medical therapy alone is generally insufficient for long-term IOP control.
Trabeculectomy is an established filtration procedure for pediatric glaucoma; however, its long-term success may be limited by aggressive postoperative wound healing and subconjunctival fibrosis. Deep sclerectomy and other non-penetrating glaucoma procedures were developed to improve aqueous drainage while reducing complications associated with conventional penetrating filtration surgery.
This study evaluated a modified surgical technique consisting of subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification). The modification involves creating a vertical deep scleral channel directed toward the limbus together with a posterior horizontal extension, forming an enlarged intrascleral filtration reservoir intended to facilitate aqueous humor drainage while maintaining controlled filtration.
This was a retrospective interventional case series conducted at the Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt. Medical records of children with primary congenital glaucoma who underwent this surgical procedure between January 2022 and June 2025 and completed at least 12 months of postoperative follow-up were reviewed.
The primary objective was to evaluate postoperative reduction in intraocular pressure. Secondary objectives included assessment of complete and qualified surgical success, reduction in the number of antiglaucoma medications, improvement in corneal clarity, changes in cup-to-disc ratio, postoperative complications, and the need for additional glaucoma surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary congenital glaucoma.
- •Age 3 years or younger at the time of diagnosis.
- •Underwent subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification).
- •Availability of complete medical records.
- •Minimum postoperative follow-up of 12 months.
排除标准
- •Secondary childhood glaucomas.
- •Associated ocular anomalies.
- •Previous glaucoma surgery.
- •Incomplete clinical records.
- •Postoperative follow-up of less than 12 months.
研究组 & 干预措施
Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy
All participants underwent subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification) for the treatment of primary congenital glaucoma. Surgical outcomes were assessed retrospectively after a minimum postoperative follow-up of 12 months.
干预措施: Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy (Procedure)
结局指标
主要结局
Change in Intraocular Pressure (IOP)
时间窗: Baseline and 12 months
Mean change in intraocular pressure (mmHg), measured by applanation tonometry or under anesthesia when necessary, from baseline to 12 months after subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy.
次要结局
- Complete Surgical Success Rate(Baseline to12 months)
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer of Ophthalmology
Benha University