One- Year Follow up of Two Models of Ahmed Glaucoma Valves (S2 and FP7) in Refractory Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .
研究概览
简要总结
The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.
详细描述
Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.
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, Investigator)
盲法说明
Coin test to choice the participants for both groups and reduce bias. Single surgeon ,highly expert in glaucoma to minimize unnecessary postoperative result changes.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
- •patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.
排除标准
- •patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits,
- •patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
- •patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
- •patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.
- •patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
结局指标
主要结局
the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .
时间窗: one-year follow up
All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP .
次要结局
未报告次要终点
研究者
khaled hamdi elbaklish
assistant professor in ophthalmology
Ain Shams University