SOLX Titanium Sapphire Laser for Trabeculoplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- SOLX, Inc.
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.
详细描述
This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Clinical Diagnosis of Open Angle Glaucoma
- •Patient is aged 18 years or older, with 2 sighted eyes.
- •Eye to be treated have average IOP greater or equal to 22 mmHg, measured at 2 pretreatment visits.
- •Eye to be treated either exhibits:
- •poorly controlled open angle glaucoma and on maximal tolerated medical therapy
- •OR poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous ALT; can treat over previous SLT)
排除标准
- •Patients are not eligible for enrollment if any of the following exclusion criteria are met:
- •Eye to be treated has any of the following:
- •evidence of glaucoma other than open-angle glaucoma;
- •severe paracentral or generalized field defect;
- •any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
- •prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
- •Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
- •Patient is pregnant.
- •Patient might require other ocular surgery within the 6-month follow-up period.
- •Patient has a medical history that suggested the potential for complications from TiSaLT.
- •Having concurrent treatment with systemic steroids.
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 1 year
次要结局
- Adverse event frequency(1 year)