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临床试验/NCT07281391
NCT07281391招募中不适用

Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients

Mann Eye Institute1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月19日最近更新:

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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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