Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months postoperatively. When this does occur, it is treated with aqueous suppressant eye drops.
This study aims to determine if it is possible to reduce the rate of hyperencapsulation phase. Patients in the treatment group will receive aqueous suppressant eye drops before the hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure is above a pre-defined level, and will target a pre-defined range.
详细描述
Patients with glaucoma requiring tube shunt surgery, with or without simultaneous cataract surgery, will be enrolled in this prospective randomized controlled study at ten sites across Canada and the United States (to be determined). Patients with highly advanced glaucoma at high risk of fixation loss, neovascular glaucoma, chronic uveitis, marked corneal disease, sulfa allergy, renal disease or any contraindication to diamox use will be excluded.
Patients scheduled for Ahmed glaucoma valve surgery, with or without cataract surgery, will be randomized using a stratified central block randomization approach to the treatment group or control group. Those scheduled for combined cataract and tube shunt will be randomized separately from those receiving tube shunt alone. Surgeons will be masked to the postoperative treatment or control group at the time of surgery since randomization will occur when the patient is one-week postoperative Those in the treatment group would receive short-term prophylactic aqueous suppression for the first 3 postoperative months to maintain intraocular pressure (IOP) between 7 and 10mmHg. The control group would not receive prophylactic aqueous suppression, but would be treated using a similar protocol as the treatment group in the event that an Hyperencapsulation phase (HEP) endpoint is met.
Prophylactic aqueous suppression in the study group would only be given for the 1st 3 months postoperatively. At the 3 month visit, aqueous suppression will be stopped. The primary outcome measure is washout IOP at 4 months postoperative. Washout IOP will be checked one month after discontinuation (earlier if needed i.e., advanced glaucoma patients).
Beyond 3 months, aqueous suppressants would be used at the clinician's discretion based on IOP.
At the conclusion of the study, the 4-month postoperative washout IOP, the incidence of HEP, the 12-month IOP, the 13-month washout IOP, and medication requirement would be compared between the treatment and control arms.
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
- Single (Outcomes Assessor)
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
- •clinical diagnosis of glaucoma
- •scheduled for Ahmed glaucoma valve surgery, with or without simultaneous cataract surgery
排除标准
- •neovascular glaucoma
- •uveitic glaucoma
- •prior tube shunt surgery
- •prior cyclodestruction procedure
- •abnormal cornea that would make IOP measurements unreliable
- •sulfa allergy
- •systemic contraindication to acetazolamide use
- •inability to attend follow up visits
- •intraocular pressure greater than 21 at postoperative week 1 (represents primary failure of the valve)
- •anterior chamber fill within the first week postoperatively
研究组 & 干预措施
Intervention Group
Patients randomized to the intervention group will receive aqueous suppressant eyedrops in a stepwise fashion in order to maintain their intraocular pressure between 7-10mmHg.
干预措施: Aqueous Suppressant Eye Drops (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 4 months postoperative
The primary outcome measure is intraocular pressure (IOP) at 4 months postoperative. This will be a washout IOP (i.e. all glaucoma eye drops will be stopped at 3 months postoperative in all study patients)
次要结局
- Absolute Ahmed Glaucoma Valve success(13 months)
- Number of glaucoma medications(12 months)
- Hyperencapsulation phase (HEP)(first 3 months postoperative)
- Qualified Ahmed Glaucoma Valve success(12 months)
研究者
Amandeep Rai
MD, Glaucoma and Advanced Anterior Segment Surgery Research Fellow, Principal Investigator
Credit Valley EyeCare