Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)
研究概览
简要总结
This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma.
The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT.
Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
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 scheduled to undergo DSLT treatment in one or both eyes.
- •Diagnosis of ocular hypertension or primary open angle glaucoma (POAG).
- •Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.
排除标准
- •Previous glaucoma surgeries/interventions:
- •Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
- •Patients who have undergone cataract surgery within the prior 2 years.
- •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.
结局指标
主要结局
Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)
时间窗: 6 months post-DSLT treatment
The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment.
次要结局
- Change in intraocular pressure (IOP) from baseline(6 months post-DSLT treatment)
- Proportion of eyes needing medication stratified by number of IOP medications required(6 months post-DSLT treatment)
- Number and type of Secondary surgical interventions(6 months post-DSLT treatment)