The Effectiveness of DSLT in Asian Normal Tension Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Intraocular Pressure (IOP)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian patients with normal tension glaucoma. The main question it aims to answer is:
Does the DSLT reduce intraocular pressure (IOP) and medication use in Asian NTG subjects? Participants will attend routine follow-up visits with their eye surgeon and glaucoma testing such as optical coherence tomography (OCT) imaging and visual field test(s) after the laser study treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian descent
- •NTG diagnosis: glaucomatous optic neuropathy in patients with IOP measurements consistently lower than 21 mmHg
- •Mean deviation (MD) of the visual field between 0 to -12dB
- •No significant central vision loss within 5 degrees within 5th percentile
- •Age ≥20 years
- •NTG patients who are medically controlled on 1-3 medications and safe to wash out or IOP is still insufficient from medications and safe to washout
- •Shaffer grade II or more on 3 of the 4 quadrants
- •Central corneal thickness (CCT) 450-600µm
- •All participants are able to provide written informed consent before participation
排除标准
- •Angle closure glaucoma or narrow angle status post laser peripheral iridotomy (LPI), or any other open angle glaucoma excluding NTG
- •History of SLT within last 2 years
- •History intraocular surgery including refractive surgery, except for history of cataract surgery that has been greater than 1 year
- •Patients anticipating cataract surgery during the study follow-up period
- •Unable to have DSLT procedure due to pre-limbal findings
- •Any presence of relevant ocular diseases including retinal disease with no confirmed cure
结局指标
主要结局
Change in Intraocular Pressure (IOP)
时间窗: 12 months post procedure
Absolute change in washed-out intraocular pressure (IOP) at 12 months compared to washed-out baseline IOP. Following a 6-week washout at baseline and again at month 11, IOP will be measured using standard tonometry to assess the effect of Direct Selective Laser Trabeculoplasty (DSLT) on pressure reduction.
次要结局
- Number of Glaucoma Medications Reduced(12 months post-procedure)
- Proportion of Patients Who Are Medication-Free(12 months post-procedure)
研究者
Ngoc Nguyen M.D.
Principal Investigator
Ngoc Nguyen Inc.