Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Intraocular pressure (IOP) evolution
研究概览
简要总结
Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.
The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Patients with poorly controlled high pressure glaucoma
- •Cyclophotocoagulation necessary to prevent visual loss
- •Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort
排除标准
- •Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
- •Patients receiving concomitant treatment the same day as the intervention
- •Patient not able to follow the prescribed post-operative treatment
结局指标
主要结局
Intraocular pressure (IOP) evolution
时间窗: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.
次要结局
- Presence of complications(During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op)
- Use of medication(1 month, 6 months, 12 months, 18 months and 24 months post-op)
- Retreatment(From the initial treatment up to the last visit (24 months))
- Visual acuity(1 month, 6 months, 12 months, 18 months and 24 months post-op)