Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of Eyes With Study Success
研究概览
简要总结
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg
详细描述
This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, age 18 to 85 years, inclusive
- •Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
- •Patient must have signed and dated the Informed Consent form
排除标准
- •Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
- •Pregnant or nursing women.
- •No light perception.
- •Active iris neovascularization or active proliferative retinopathy.
- •Iridocorneal endothelial syndrome.
- •Epithelial or fibrous downgrowth.
- •Pseudoexfoliative glaucoma
- •Vitreous in anterior chamber for which a vitrectomy is anticipated.
- •Corneal disease
- •Acute, chronic or recurrent uveitis.
- •Severe posterior blepharitis.
- •Unwilling to discontinue contact lens use after surgery.
- •Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
- •Prior cataract surgery involving a conjunctival incision
- •Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
- •Less than 0.1 (20/200) visual acuity in the non-test eye.
- •Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.
研究组 & 干预措施
MIDI Arrow
Implantation of MIDI Arrow
干预措施: MIDI Arrow (Device)
结局指标
主要结局
Number of Eyes With Study Success
时间窗: Months 6, 9, 12 and 24
The rate of success reflected sustained control of IOP over 24 Months from baseline
次要结局
- IOP Change From Baseline(At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24)