Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- IOP Reduction
研究概览
简要总结
A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients
详细描述
A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.
Patients will be followed up for at least one year during which the following data are collected.
Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded
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
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years.
- •The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.
排除标准
- •Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.
研究组 & 干预措施
Paul Glaucoma Implant
The Paul glaucoma implant (PGI) will be used as an active comparator group to compare its effectiveness and safety with the Ahmed glaucoma valve in the treatment of childhood glaucoma. The PGI works by diverting excess fluid from the eye to a plate placed under the conjunctiva, which allows the fluid to drain away from the eye and be absorbed. This helps to lower the pressure inside the eye, which is important for preventing vision loss and other complications associated with glaucoma.
The PGI has a smaller internal and external tube diameter than the Ahmed glaucoma valve, which reduces the contact area between the tube and the corneal endothelium. This theoretically reduces the rate of endothelial cell loss, which can be a complication of GDDs. Additionally, the extraocular portion of the PGI is smaller, which may reduce the long-term risk of tube erosion and exposure.
The smaller lumen may theoretically reduce the risk of postoperative hypotony as well.
干预措施: Glaucoma Drainage Device (Device)
Ahmed Glaucoma valve
The Ahmed glaucoma valve (AGV) arm of the study is the active comparator group and is intended to be directly compared to the Paul glaucoma implant (PGI) in treating childhood glaucoma. The AGV is a type of glaucoma drainage device that is designed to lower intraocular pressure in patients with refractory glaucoma. It is made of a rigid plastic material and consists of a small drainage tube that is inserted into the eye and a valve mechanism that helps regulate the flow of aqueous humor from the eye to the external drainage tube.
The AGV is implanted during a surgical procedure, and its design allows it to be placed in a variety of locations in the eye. The valve mechanism helps to regulate the flow of aqueous humor, and the device is designed to be long-lasting with a low risk of complications. The AGV is a well-established treatment option for patients with refractory glaucoma and has been used for many years in clinical practice.
干预措施: Glaucoma Drainage Device (Device)
结局指标
主要结局
IOP Reduction
时间窗: 1 year
More than 20% change from baseline without development of vision threatening complications
次要结局
- Post-operative complications(1 year)
- Glaucoma Medication Alterations(1 year)
研究者
Mohamed El Baharwy
Clinical Professor
Al Watany Eye Hospital