Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Santen SAS
- 入组人数
- 112
- 试验地点
- 11
- 主要终点
- Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
研究概览
简要总结
The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.
详细描述
This is a prospective, multicentric, single arm post market clinical follow-up study to collect safety and performance data on the CE Marked PRESERFLO™ MicroShunt XI device in patients with primary open angle glaucoma. The PRESERFLO™MicroShunt XI employs a tube to create a conduit for the flow of aqueous humor from the anterior chamber of the eye to a bleb formed under the conjunctiva and Tenon's capsule; the front/ proximal end of the tube extends into the anterior chamber while the back/ distal end terminates in the bleb. The PRESERFLO™MicroShunt XI reduces IOP by physically shunting aqueous humor from the high pressure anterior chamber to the lower pressure bleb. The intended users of the PRESERFLO™ MicroShunt XI are ophthalmologists/ophthalmic surgeons specialized in the treatment of glaucoma (including surgeons specialized in anterior segment and cataract surgery) who have been trained to use the device. No biospecimens are collected in this study and no control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, age 18 to 85 years, inclusive
- •Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications
- •Patient willing to comply with study requirements
- •Patient who has signed an approved informed consent form
排除标准
- •Angle closure glaucoma
- •Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
- •Active iris neovascularization
- •Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
- •Vitreous in the anterior chamber
- •Presence of an anterior chamber intraocular lens (ACIOL)
- •Intraocular silicone oil
- •Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period
- •Central corneal thickness that is less than 450 microns or greater than 620 microns
- •Previous cilioablative procedure
- •Neovascular glaucoma
- •Uveitic Glaucoma
- •Pseudoexfoliative or pigmentary glaucoma
- •Chronic inflammation
- •Previous incisional ophthalmic surgery within 6 months prior to study
- •Enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam
- •Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the patient at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the Protocol
研究组 & 干预措施
Microshunt XI treatment group
MicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.
干预措施: Microshunt XI (Device)
结局指标
主要结局
Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
时间窗: Screening to 12 months
This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \<21 mmHg intraocular pressure from screening to 12 months
次要结局
- Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure(At 12 months)