Prospective Evaluation of the Efficacy of Pascal Trabeculoplasty: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- intraocular pressure
研究概览
简要总结
Laser Trabeculoplasty has been shown to be effective in lowering intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). Although initially demonstrated with the Argon laser (ALT), several other laser systems have also been employed with comparable efficacy. Recently, Selective Laser Trabeculoplasty (SLT) has been shown to lower intraocular pressure comparable to ALT. The advantage of SLT is that the target eye structure, the trabecular meshwork, remains intact with minimal damage at the cellular level. In contrast, ALT lowers IOP at the expense of scarring of the trabecular meshwork. The purpose of this study is to evaluate the efficacy of lowering IOP with Pascal Laser Trabeculoplasty (PLT) employing reduced energy levels compared to ALT and a computer guided pattern of laser treatment applications.
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
- 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
- •Otherwise healthy males and females, older than 18 years of age with two (2) sighted eyes
- •Have OAG, PXG, or combined mechanism glaucoma - as long as their angles are open
- •Have uncontrolled IOP (>24mmHg); or controlled with Medicine(s)
- •If on medical treatment, have undergone a washout period of at least one month prior to Pascal treatment
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Able to provide written informed consent
排除标准
- •Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- •Have an advanced visual field defect within 10° of fixation
- •Have had previous glaucoma surgery, except for peripheral iridotomy
- •Have corneal disease obviating the use of corneal applanation for a reliable IOP measurement, or would cause difficulty in viewing the TM by means of gonioscopic lens
- •Using systemic steroids
- •Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
- •No concomitant use of IOP lowering medicine (Group 1)
- •No co-existing ocular pathology with the exception of Cataract.
结局指标
主要结局
intraocular pressure
时间窗: 1 week, 1 month, 3 months, 6 months, 9 months and 1 year after treatment
次要结局
未报告次要终点