iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in the number of intraocular pressure lowering medications compared to baseline
研究概览
简要总结
The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
详细描述
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only one eye per participant
- •Clinically significant cataract
- •Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
- •Open chamber angle with Schaffer grading three to four in at least two quadrants
排除标准
- •Previous glaucoma surgery, including cyclodestructive procedures.
- •Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
- •Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
- •Unable to participate and make written consent due to another medical condition.
研究组 & 干预措施
Procedure: iStent
Cataract surgery in combination with iStent Inject W implantation
干预措施: Two iStent inject implanation (Device)
Procedure: KDB
Cataract surgery combined with Kahook Dual Blade goniotomy.
干预措施: Goniotomy with KDB blade goniotomy (Device)
结局指标
主要结局
Change in the number of intraocular pressure lowering medications compared to baseline
时间窗: From enrollment to the end of treatment at 12 months
Accountability of intraocular pressure lowering medications used by the patient
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
时间窗: From enrollment to the end of treatment at 12 months
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
次要结局
- Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg(From enrollment to the end of treatment at 12 months)