NCT06991270招募中不适用
A Pilot Study of the OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).
详细描述
To assess the safety of the OMNI 3.0 Surgical System and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG).
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 and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.
- •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). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage
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 (e.g., wet age-related macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). Dry AMD and Non- proliferative diabetic retinopathy are not excluded.
- •History of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable IOP measurement, e.g. keratoconus or abnormally thick (≥ 620 µM) or thin (≤ 480 µM) cornea.
- •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
OMNI 3.0
Experimental
Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes.
干预措施: OMNI 3.0 Surgical System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 3 months
Proportion of subjects with a ≥ 20% reduction 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
- Secondary Effectiveness Endpoint 1(3 months)
- Secondary Effectiveness Endpoint 2(3 months)
研究者
研究点 (1)
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