NCT03469297已完成不适用
Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
MicroOptx6 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Overall Responder Rate
研究概览
简要总结
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of up to 10 subjects will be enrolled at three centers. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.
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
- •Age 22 years and older.
- •Best corrected visual acuity of 20/400 or worse.in the study eye.
- •Fellow eye with visually acuity of 20/200 or better and the visual field no worse than the study eye. If the study eye has no light perception, the fellow eye may have no light perception or better.
- •Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg.
- •Primary open-angle glaucoma (confirmed by gonioscopy).
- •Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: (1) Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; (2) Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or (3) Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
- •Humphrey Visual Field (HVF) demonstrating visual field defects consistent with glaucomatous optic nerve damage.
- •At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 03:00 in the study eye.
- •Adequate space in the anterior chamber of the study eye sufficient to support implant with the BGI, defined as two contiguous clock hours of scleral spur visualization via goinioscopy, without compression, in the superior 180 degrees of the anterior angle.
- •Able and willing to comply with protocol requirements.
- •Able to understand and sign the Informed Consent form.
排除标准
- •Active Neovascular Glaucoma in the study eye.
- •Pigmentary Glaucoma in the study eye.
- •Pseudoexfoliative Glaucoma in the study eye.
- •Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber.
- •Anticipated need for ocular surgery within one year in the study eye.
- •Requirement of a combined glaucoma procedure in the study eye.
- •Contact lens use in the study eye.
- •Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
- •Other clinical conditions:
- •Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >
- •Cancer requiring treatment during the duration of the study.
- •Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.
- •Participation in any other clinical trial during participation in this trial.
- •Life expectancy <1 year.
- •If both eyes of a prospective trial participant are eligible, only the eye with the highest intraocular pressure will be selected for implant.
结局指标
主要结局
Overall Responder Rate
时间窗: 6 Months
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Adverse Event Rate
时间窗: 6 Months
Rate of all AEs
次要结局
- Mean Change From Baseline in IOP(Baseline, 6 Months)
- Change in IOP-lowering Medications(Baseline, 6 Months)
- Alternative Responder Rate(6 Months)
研究者
研究点 (6)
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