NCT04465630终止不适用
A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 22
- 主要终点
- Change in Intraocular Pressure (IOP)
研究概览
简要总结
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 22 years or older at the time of surgery
- •History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.
- •Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- •Mean deviation score must be better than or equal to -12.0 dB
- •The visual field test may be historical (within 6 months prior to Screening Visit). If needed, visual field testing may be repeated between the Screening Visit and the Surgery Visit.
- •At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months.
- •At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24
- •Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
- •Shaffer grade of ≥ III in all four quadrants
- •Able and willing to comply with the protocol, including all follow-up visits.
- •Understands and signs the informed consent
排除标准
- •Any of the following prior treatments for glaucoma:
- •Laser trabeculoplasty ≤3 months prior to Baseline visit
- •iStent or iStent Inject implanted ≤6 months prior to Baseline visit
- •Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline visit
- •Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
- •Prior canaloplasty, goniotomy, or trabeculotomy
- •Hydrus microstent
- •Suprachoroidal stent (e.g. Cypass, iStent Supra)
- •Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- •Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)
- •In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
- •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 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).
- •History of penetrating keratoplasty or another corneal transplant
- •BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract
- •Study of OMNI System in POAG
- •BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is permitted only if there is no vitreous present in or in front of the iris plane at the time of baseline).
- •Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
- •Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
结局指标
主要结局
Change in Intraocular Pressure (IOP)
时间窗: 6 months
Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
次要结局
- Change in Number of Medications(6 months)
研究者
研究点 (22)
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