Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated With Selective Laser Trabeculoplasty (SLT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients.
Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT.
The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment.
The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.
详细描述
This is a prospective, single-arm, interventional study designed to evaluate the safety and effectiveness of direct selective laser trabeculoplasty (DSLT) using the Voyager™ DSLT system in patients with ocular hypertension or primary open-angle glaucoma who have previously undergone selective laser trabeculoplasty (SLT).
DSLT is a non-contact laser procedure that delivers energy to the trabecular meshwork through the limbus without requiring a gonioscopy lens. The procedure in this study is standardized, consisting of 120 laser applications delivered over 360 degrees using a 400 µm spot size and fixed energy of 1.8 mJ, without titration. Treatment is performed in a single eye per participant.
To minimize the confounding effects of topical ocular hypotensive medications, participants using such therapies at screening will undergo a protocol-defined washout period prior to baseline intraocular pressure (IOP) assessment and treatment. Additional washout is required prior to the 6-month follow-up assessment to allow for evaluation of treatment effect independent of adjunctive pharmacologic therapy.
IOP is measured using Goldmann applanation tonometry at defined study visits. During follow-up, initiation of IOP-lowering medications is permitted based on investigator-defined target IOP thresholds and clinical judgment. Criteria for treatment escalation and definitions of treatment failure, including the need for secondary glaucoma procedures or ocular surgery that may affect IOP, are specified in the protocol.
This study specifically evaluates the performance of DSLT in a population with prior SLT exposure, for whom the magnitude and durability of response to repeat or alternative laser therapy are not well established. The study is intended to generate data on IOP control and safety outcomes in this clinically relevant subgroup under standardized treatment and follow-up conditions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye.
- •Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG).
- •Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 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).
- •Recent SLT failures (within 6 months of initial treatment).
- •Patients who have undergone cataract surgery within the prior 2 years.
- •Secondary glaucoma:
- •o 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.
研究组 & 干预措施
DSLT Treatment
Participants undergo direct selective laser trabeculoplasty (DSLT) in one eye using a fixed-energy protocol (120 shots, 400 µm spot size, 1.8 mJ, no titration). Intraocular pressure (IOP) is assessed at baseline (following medication washout) and during follow-up visits at 1 month, 3 months, and 6 months. A medication washout is required prior to baseline and the 6-month assessment. IOP-lowering medications may be introduced during follow-up based on investigator-defined thresholds.
干预措施: DSLT (Device)