A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intra-procedural and post-procedural adverse events
研究概览
简要总结
The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Male or female subjects, 18 years or older.
- •Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must include evidence of:
- •Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
- •Visual field abnormality (substantiated with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be -15dB < MD < 0dB.
- •Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:
- •Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
- •Greater than or equal to 22mmHg at both Eligibility Visits.
- •Subjects currently using one or more topical medications to control their IOP.
- •Subjects able and willing to comply with the protocol, including randomization assignment and all follow-up visits.
- •Subjects that sign the informed consent form.
排除标准
- •Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- •Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g., pseudo exfoliation or pigmentary glaucoma).
- •Other exclusion criteria apply
研究组 & 干预措施
DWT device dose A
Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).
干预措施: DWT device dose A (Device)
Ellex Tango SLT machine
Selective Laser Trabeculoplasty (SLT)
干预措施: Ellex Tango SLT machine (Device)
DWT Sham
Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.
干预措施: DWT sham (Device)
DWT device dose B
Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).
干预措施: DWT device dose B (Device)
结局指标
主要结局
Intra-procedural and post-procedural adverse events
时间窗: 6 months
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
时间窗: 6 months
次要结局
未报告次要终点