NCT05371977招募中不适用
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Success Rate
研究概览
简要总结
The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.
详细描述
Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
- •Glaucoma unstable with current medication assessed by a glaucoma specialist
排除标准
- •Secondary Glaucoma e.g. due to previous injury or uveitis
- •Exfoliation syndrome
- •Pigment dispersion syndrome
- •Previous transscleral or endoscopic cyclophotocoagulation
- •Previous other glaucoma surgery
- •Previous retinal detachment
- •Previous intraocular surgery like vitrectomy and other retinal surgery
- •Wet age-related macular degeneration
- •Diabetic retonopathy
- •Previous corneal transplant or previous refractive surgery
- •Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
- •The patient does not want to participate in the study
- •The patient does not speak Finnish, Swedish or English
- •Only eye with vision worse than 20/200 or loss of central visual field
结局指标
主要结局
Success Rate
时间窗: One year
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
次要结局
- Success Rate(5 years)
研究者
Nina Lindbohm
Principal Investigator
Helsinki University Central Hospital
研究点 (2)
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