Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- glaucoma medications
研究概览
简要总结
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in refractory glaucoma cases in order to compare it with the Ahmed implant.
详细描述
Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of Baerveldt implant or Ahmed implant models using a standardized surgical technique.
The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.
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
A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 - patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
- •2- patients who had secondary glaucoma and are known to have a high failure rate with trabeculectomy such as neovascular, uveitis, or iridocorneal endothelial syndrome-associated glaucoma, were included in the study.
排除标准
- •1 - patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
- •2-had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
- •3- presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
- •4-uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
结局指标
主要结局
glaucoma medications
时间窗: one year follow up
mean number of glaucoma medications
IOP
时间窗: one year follow up
mean IOPs
次要结局
- visual acuity(one year follow up)
研究者
khaled hamdi elbaklish
principal investigator
Ain Shams University