NCT07281391招募中不适用
Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP
研究概览
简要总结
This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
- •Treatment naive, or washed out IOP ranging from ≥18-34 mmHg
- •Central corneal thickness (CCT) 480-600 µm
- •Able to complete medication washout and follow-up
排除标准
- •Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
- •Prior laser trabeculoplasty <3 years
- •Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years
- •Patients anticipating cataract surgery within the follow-up period
- •History of ocular inflammation and infection
- •All other secondary glaucoma including exfoliative
- •Patients unable to have DSLT treatment
结局指标
主要结局
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP
时间窗: 6 months post-DSLT
次要结局
- Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP(6 months post-DSLT)
- Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications(6 months post-DSLT)
- Change in number of glaucoma medication(s)(6 months post-DSLT)
- Proportion of medication free eyes post-DSLT(6 months post-DSLT)
- Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP(12 months post-DSLT)
- Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications(12 months post-DSLT)
- Change in number of glaucoma medication(s)(12 months post-DSLT)
- Proportion of medication free eyes post-DSLT(12 months post-DSLT)
研究者
研究点 (1)
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