IOP Reduction and Complications of Polymethyl Methacrylate Glaucoma Drainage Device on Glaucoma Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients
研究概览
简要总结
Glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. The aim of glaucoma management is to reduce IOP, and glaucoma implant surgery is the alternative treatment that can be chosen. The effectiveness of the implant on the end stage glaucoma patients was evaluated by the reduction of intra ocular pressure (IOP) and well formed blebs that were evaluated clinically and by using anterior scanning optical coherence tomography (AS-OCT). The safety of the implant was determined by the regression of the clinical symptoms and there were no severe complications such as implant extrusion. Two patients developed improvement of the visual acuity. This was an unpredictable positive result.
详细描述
The study is to measure the efficacy of new GDD that made with polymethyl methacrylate. The primary outcome is IOP reduction. The secondary outcome is glaucoma medication post surgery and complication that occurred during the follow up. The subjects are refractory glaucoma patients that need glaucoma drainage device implantation. The measurement are collected on first day, first month, third month, sixth month and twelve month. The IOP will be measured using GAT (Goldmann applanation tonometer), but if the subjects are not cooperative, they will be measured using i-care. On the follow up, the glaucoma medication needed will be noted and also for the complication and the need for other surgery, e.g. AC formation using viscoelastic, repair tube/plate exposure, cyclo photocoagulation, etc.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage glaucoma patients whose IOP is failed to be controlled by glaucoma medications
- •Patients that are willing to participate in the study
- •Patients with <6/60 visual acuity
- •Patients above 18 years
排除标准
- •Patients with combination surgery indication (eg. glaucoma with cataracts)
- •Eyes with congenital disease of anterior segment dysgenesis
- •Eyes with uneven surface of the cornea that the measurement IOP with Goldmann tonometer could be difficult
- •Eyes with broad conjungtival cicatrix that are impossible to be implanted
研究组 & 干预措施
Glaucoma drainage device in glaucoma patient
GDD is inserted in glaucoma patients
干预措施: Glaucoma Implant (Procedure)
结局指标
主要结局
IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients
时间窗: pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery
Intraocular pressure (IOP)
次要结局
- The glaucoma medication that was used pre and post operative(pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery)
- The complications that occurred during the follow up(during the surgery, day 1, 7, 30, 60, 90 post implantation surgery)
研究者
Dr. dr. Virna Dwi Oktariana, SpM(K)
Principal Investigator
Indonesia University