A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
研究概览
简要总结
The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to 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 as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 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
- 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
- 是
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.
结局指标
主要结局
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
时间窗: 12 to 24 months
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Change in the number of intraocular pressure lowering medications compared to baseline
时间窗: 12 to 24 months
Accountability of intraocular pressure lowering medications used by the patient
次要结局
- Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg(12 to 24 months)
研究者
Anna Barkander
Principal Investigator
Umeå University