Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Non-Caucasian Open Angle Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.
研究概览
简要总结
The goal of this clinical trial is to to evaluate how well Direct Selective Laser Trabeculoplasty (DSLT) lowers eye pressure in eyes of adult, non-Caucasian participants with primary open angle glaucoma. The main question it aims to answer is:
What is the washed out eye pressure (eye pressure when not on any glaucoma medications) of participants 6 months after the Direct Selective Laser Trabeculoplasty (DSLT) procedure compared to the washed out eye pressure of participants prior to the DSLT procedure.
Participants will:
Undergo the DSLT procedure in one or both eyes and visit the clinic 1 month, 3 months, and 6 months after the procedure to have their vision and eye pressure measured.
详细描述
The goal of this clinical trial is to evaluate intraocular pressure (IOP) reduction of Direct Selective Laser Trabeculoplasty (DSLT) treatment in eyes of non-Caucasian patients with primary open angle glaucoma by assessing the washed out IOP reduction of DSLT at 6 months (compared to washed out baseline IOP), measuring the success rate of achieving ≥ to 20% IOP reduction from washed out baseline, assessing the proportion of medication-free eyes at 6 months post-DSLT, the need for secondary intervention (additional medications or procedures) at 6 months post-DSLT, and by comparing the washed out IOP reduction at 6 months post-DSLT compared to the washed out baseline IOP according to trabecular meshwork pigmentation grade.
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
- •Adult patients of Black African descent scheduled to undergo DSLT treatment in one or both eyes.
- •Diagnosis of mild to moderate primary open angle glaucoma (POAG).
- •Mild to moderate POAG will be defined as Stage 2 or better of the Hodapp-Anderson-Parrish glaucoma staging system.
- •Treatment naive or washed out IOP at time 0 ranging from ≥ 21 through 32 mm Hg.
排除标准
- •Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0).
- •Previous glaucoma surgeries/interventions:
- •Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
- •Secondary glaucoma:
- •Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.
- •Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.
- •Subjects who are pregnant, breast-feeding, or intend to become pregnant during the study period as determined by verbal inquiry.
结局指标
主要结局
IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.
时间窗: 6 Months post-DSLT
次要结局
- Proportion of eyes with ≥ 20% washed out IOP reduction at 6 months post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP.(6 months post-DSLT)
- The number of participants who require secondary interventions (additional IOP-lowering procedures) prior to the completion of the 6 month post-DSLT visit.(6 Months Post-DSLT)
- The number of participants who require secondary interventions (additional IOP-lowering medications) prior to the completion of the 6 month post-DSLT visit.(6 Months Post-DSLT)
- Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP(1 month and 3 months post-DSLT)
- Proportion of medication free eyes at 6 months post-DSLT(6 Months Post-DSLT)
- Mean 6 month washed out IOP reduction compared with washed out baseline IOP stratified by Trabecular Meshwork pigmentation grade.(6 Month Post-DSLT)