Efficacy of Selective Laser Trabeculoplasty Targeting Nasal Versus Inferior 180-degree
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Difference in mean intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study to optimize Selective Laser Trabeculoplasty (SLT) application when used in the management of open angle glaucoma (OAG)
详细描述
The purpose of this research is to determine the most effective method in using Selective Laser Trabeculoplasty (SLT) for lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. We will investigate the IOP lowering differences between nasal 180° SLT and inferior 180° SLT,. The second stage will assess the effect of repeating SLT in the opposite 180° sector after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age 18 years and older
- •Ability to comprehend the study procedures and agreement to proceed with primary SLT treatment
- •Diagnosis of primary or secondary open angle glaucoma or glaucoma suspects with ocular hypertension
- •Bilateral disease
- •Pre-SLT IOP >21 mmHg measured at least twice during patient's lifetime with or without medication
- •Open angles with moderate to intense trabecular pigmentation
- •Mild to moderate visual field defects (24-2 standard mean deviations better than the Swedish interactive thresholding algorithm standard of 12 dB)
- •No adequate IOP control (low treatment compliance, substantial adverse effects with eyedrops, and at least 2 IOP measurements higher than the individualized target IOP)
排除标准
- •Unwilling or unable to give consent
- •Unable to attend scheduled post-operative visits
- •Previous history of either laser treatment or intraocular surgery, except for non-complicated cataract surgery (performed >6 months before SLT)
- •History of ocular trauma
- •Narrow angles
- •Retinal detachment
- •Active iris neovascularization or active proliferative retinopathy
- •Active uveitis
- •Monocular patients
- •Current use of steroids (ocular, periocular, or systemic)
结局指标
主要结局
Difference in mean intraocular pressure (IOP)
时间窗: Baseline, 3 months, 6 months, 9 months
During each visit, two consecutive IOP measurements will be obtained per eye, and the average of these values will be reported.
次要结局
- Change in intraocular pressure (IOP)(Baseline, 3 months, 6 months, 9 months)
- Intraocular pressure (IOP) lowering eye drops(9 months)
研究者
Arthur J. Sit, M.D.
Principal Investigator
Mayo Clinic