A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma (POAG) and Cataract.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- ≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint
研究概览
简要总结
A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.
详细描述
To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 45 years or older
- •Visually significant age-related cataract.
- •Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
- •Diagnosed with mild to moderate primary open angle glaucoma (POAG).
排除标准
- •Any of the following prior ocular procedures:
- •Laser trabeculoplasty ≤180 days prior to baseline
- •Durysta ≤12 months prior to baseline
- •Any implanted glaucoma device
- •Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
- •Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU),
- •180 days prior to baseline
- •Retinal laser procedure ≤3 months prior to baseline
- •Any form of glaucoma other than POAG
- •Use of topical ocular steroids.
- •Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol
- •History of penetrating keratoplasty or another corneal transplant
- •Endothelial cell density < 2200 cells/mm2 (age 45), < 2000 cells/mm2 (age 46 to 55), < 1800 cells/mm2 (age 56 to 65), < 1600 cells/mm2 (age > 65).
- •Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
- •BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract
- •BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
研究组 & 干预措施
POAG and Cataracts
Subjects diagnosed with mild to moderate primary open angle glaucoma (POAG) and cataracts in the study eye.
干预措施: Helix Surgical System (Device)
结局指标
主要结局
≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint
时间窗: 3 months
Proportion of subjects with a ≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively.
次要结局
- Change in mean IOP(3 months)
- Average number of ocular hypotensive medications(3 months)