Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change In IOP
研究概览
简要总结
The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.
详细描述
Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved
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
- 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
- •Diagnose of glaucoma
- •Indication to be submitted to the procedure
排除标准
- •Significant thinning of the sclera
- •Current eye infection or inflammation
- •Intraocular surgery performed less than 2 months prior to the enrollment in the study
结局指标
主要结局
Change In IOP
时间窗: Baseline, 12 months post procedure
Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)
次要结局
- Number of anti-glaucoma medications(12 months)
- Complications(12 months)
- Change in cup-disc ratio(Baseline, 12 months post procedure)
- Change in visual field(Baseline, 12 months post procedure)
- Change in visual acuity(Baseline, 12 months post procedure)
- Change in iris color(Baseline, 12 months post procedure)
研究者
Syril K. Dorairaj
Principal Investigator
Mayo Clinic