The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 44
- 主要终点
- Number of Eyes That Failed Treatment
研究概览
简要总结
Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.
详细描述
This is a study comparing short- (1 year), mid- (3 years), and long-term (5 years) cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous tube shunt procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men 18 to 85 years of age
- •Glaucoma not adequately controlled (IOP >18 mmHg on maximum tolerated topical therapy) with a single aqueous shunt (AS).
- •Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye
排除标准
- •Monocular
- •Presence of more than one AS in the study eye
- •Previous cyclodestruction in the study eye
- •Presence of active iris neovascularization in the study eye
- •Binocular diplopia
- •Presence of scleral buckle in the study eye
- •History or scleritis in either eye
- •History of scleromalacia in the study eye
- •Insufficient conjunctiva to cover AS in the study eye
- •IOP cannot be accurately measured with Goldmann applanation, Pneumotonometry, or Tono-Pen in the study eye
- •Presence of silicone oil in the study eye
- •Presence of retinal detachment in the study eye
- •Presence of intraocular or orbital tumor affecting the study eye
- •Need for cataract extraction or concurrent procedure at the time of study treatment, except tectonic aqueous shunt revisions for both groups is allowed.
- •In the opinion of the investigator, should not be enrolled in this study
- •Unwilling or unable to give consent and satisfy requirements of the study
结局指标
主要结局
Number of Eyes That Failed Treatment
时间窗: from month 12 to year 3
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
次要结局
- Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test(from time of intervention to year 3)
- Severity of Pain(1 month)
- Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale(baseline)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale(month 12)
- Number of Eyes With Vision-threatening Complications(from the time of intervention to year 3)
- Number of Office Visits Per Participant From Baseline to 3 Months(from baseline to 3 months)
- Number of Office Visits Per Participant Per Month After Month 3(from month 4 to year 3)
- Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test(baseline, year 3)
- Incidence of Pain(1 month)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale(month 12)
- Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale(month 12)
研究者
Robert Feldman
M.D.
The University of Texas Health Science Center, Houston