NCT07401290尚未招募不适用
The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Primary Effective Endpoint
研究概览
简要总结
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with pseudoexfoliation glaucoma (PXFG), with optic neuropathy consistent with glaucomatous damage of any severity
- •Open iridocorneal angle by gonioscopy, defined as a Shafer Grade II or greater
- •Treatment naive, or washed out IOP ranging from ≥18-35 mmHg
- •Able to complete medication washout safely and all follow-up visits
- •Participants must have a best correct visual acuity of 20/40 or better in the study eye(s), be able to undertake a reliable Humphrey visual field (HVF) (defined as fixation losses, false positives and false negatives less than 33%), and must have field loss no worse than -20 dB in treatment eye
排除标准
- •Any contraindication to SLT or unable to have DSLT
- •Angle closure glaucoma or any other types of glaucoma other than PXFG
- •Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
- •Any prior refractive surgery
- •H/o LPI within last 6 months
- •A history of any significant cataract required during study duration or cataract surgery in the last 6 months
- •Prior laser trabeculoplasty (ALT/SLT)
- •History of ocular inflammation and infection
- •Patients who are pregnant or have any clinically relevant systemic disease that may prevent them from reliably completing follow-up visits
- •Vulnerable populations that cannot provide proper informed consent will not be enrolled, such as children, prisoners, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons
研究组 & 干预措施
Treated Group
Experimental
Patients treated with DSLT
干预措施: Direct selective laser trabeculoplasty (Device)
结局指标
主要结局
Primary Effective Endpoint
时间窗: 6 months
Proportion of eyes achieving ≥20% reduction in washed-out IOP at month 6 compared to washed-out baseline IOP
次要结局
- Secondary Effective Endpoint(12 months)
- Secondary Effective Endpoint(6 and 12 months)
研究者
Lorraine Provencher
Sponsor-Investigator
Vance Thompson Vision
研究点 (3)
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