NCT01774227已完成不适用
A Randomized Trial of the Pops-titration Versus the Slow-coagulation Energy Delivery Technique on the Outcome of Diode Laser Transcleral Cyclophotocoagulation in Treatment of Neovascular Glaucoma With Dark Iris
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
- Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
- Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
- The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
- The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
- The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients.
详细描述
- Several protocols afford delivery of the "optimum" dose of laser energy per session necessary to achieve a long-term effective ocular hypotensive response balancing risks related to a high energy treatment and risks related to retreatment due to suboptimum dose delivery.
- There are two main approaches to delivering laser energy, the pops-titration method and the fixed energy method that are the fixed-high and low-energy (the Gaasterland's slow-coagulation technique).
- Of particular interest is which laser energy delivery method (slow-coagulation versus pops-titration) affords the optimal dose of photocoagulation necessary to achieve an effective long-term intraocular pressure (IOP) reduction while minimizing the risk of adverse events related to overtreatment and retreatments especially in refractory glaucomatous eyes with dark iris color.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory glaucoma (Neovascular glaucoma) with
- •Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure will probably cause corneal complications
- •Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure cause eye pain and need pain relief
- •Eyes with minimal useful vision and intraocular pressure over the target intraocular pressure
- •Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have a high probability of failure
- •Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have previously failed
- •Patient refuses to undergo more aggressive intraocular surgery
- •Patients whose general medical condition precludes invasive surgery
排除标准
- •The visual acuity in the fellow eye is no light perception
- •Have previously been treated by the transcleral cyclophotocoagulation
- •Allergy to anesthetic medication
- •Can not measure the intraocular pressure by the applanation method
研究组 & 干预措施
The pops-titration group
Experimental
The titration method uses power that is titrated according to the audible "pop".
干预措施: The pops-titration group (Procedure)
The slow-coagulation group
Experimental
The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique
干预措施: The slow-coagulation group (Procedure)
结局指标
主要结局
Success rate
时间窗: 60 months
Success rate defined as the proportion of eyes achieving an intraocular pressure between 6 and 21mmHg with or without topical antiglaucoma medication at the final follow up visit.
次要结局
- Response rate(60 months)
- Cyclodiode efficacy index(60 months)
- Failure rate(60 months)
研究者
Weerawat Kiddee
Dr.Weerawat Kiddee
Prince of Songkla University
研究点 (1)
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