NCT02312362Unknown不适用
HFDS ab Interno - to Compare Intraocular Pressure (IOP) Lowering Effect of Combined High Frequency Deep Sclerotomy ab Interno (HFDS ab Interno) With Phacoemulsification and Phacoemulsification Alone, in Primary Open Angle Glaucoma Patients
Oertli Instrumente AG5 个研究点 分布在 4 个国家目标入组 108 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- Intraocular pressure
研究概览
简要总结
Objective:
To compare intraocular pressure lowering effect of combined sclerotomy ab interno with phacoemulsification and phacoemulsification alone, in primary or secondary open angle glaucoma patients.
Study design:
Prospective, randomized, case- control interventional surgical trial
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.
排除标准
- •One eyed patients
- •Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
- •The presence of extreme narrow angle with complete or partial closure in either eye, except for occludable angles treated with a patent iridectomy
- •Any abnormality preventing reliable applanation tonometry, any opacity or patient uncooperativeness that would restrict adequate examination of the ocular fundus or anterior chamber of either eye
- •The risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's opinion
- •Any clinically significant, serious, or severe medical or psychiatric condition; any condition that, in the investigator's opinion, would interfere with optimal participation in the study or present a special risk to the patient
- •Participation in any other investigational study within 30 days prior to baseline visit
结局指标
主要结局
Intraocular pressure
时间窗: Baseline screening till 3 year post-op
decrease in anti glaucoma medications
时间窗: Baseline screening till 3 year post-op
visual acuity
时间窗: Baseline screening till 3 year post-op
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects.glaucoma, ocular hypertensionJPRN-UMIN000003810Department of Ophthalmology, Houju Memorial Hospital25
已完成
3 期
A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI StudyPrimary Open Angle Glaucoma or Ocular HypertensionNCT02822742Santen Pharmaceutical Co., Ltd.26
已完成
4 期
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)Angle-closure GlaucomaNCT00762645Alcon Research30
已完成
3 期
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular HypertensionOpen-angle Glaucoma, Ocular HypertensionNCT03822559Santen Pharmaceutical Co., Ltd.219
尚未招募
不适用
Comparison of the lowering intraocular pressure after trabeculotomy between patients with and without response to Ripasudil.1. Glaucoma 2. Ocular hypertentionJPRN-UMIN000023227Department of Ophthalmology Hokkaido university Graduate School of Medicine40