Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ciliatech
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Assess post-op IOP reduction
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
详细描述
22 patients will be included in this 36 months interventional study.
All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.
Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.
Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 50 years old
- •Patient dated and signed the informed consent form to participate in the study at first visit
- •Phakic, pseudophakic or aphakic eye
- •Has medically treated open-angle glaucoma (schaffer grade 3 and 4)
- •The optimal medical treatment against glaucoma for this eye has failed i. Preoperative treatment ≥ 2 molecules with target IOP not reached despite medication, ii. or IOP ≥ 21 mmHg under treatment, iii. or patient not compliant with treatment, iv. or patient intolerant to treatment
- •Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months.
- •Having the indication for glaucoma surgery alone
排除标准
- •Patient with visual acuity of the contralateral eye greater than LogMar 0.
- •If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7
- •Patient with a known allergy to any of the constituents of the products used in this study
- •Patient already included in another study
- •A person protected by law (temporary or permanent guardianship) or not capable of discernment
- •Presenting with inflammatory glaucoma
- •Presenting with congenital glaucoma
- •Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
- •Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.)
- •Having had eye surgery (other than glaucoma) less than 6 months ago
- •Closed angle, grade 1 or 2 Schafer OAG
- •Pre-existing ocular or systemic pathology that may cause post operative complications such as:
- •Clinically significant inflammation such as uveitis
- •Eye infection
- •Anterior segment neovascular disease
- •Severe dry eye syndrome
- •Severe blepharitis
- •Retinopathy which can lead to neovascular complications in the anterior segment
- •Eye of axial length <20 mm
- •Eye with lens dislocation or subluxation
结局指标
主要结局
Assess post-op IOP reduction
时间窗: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success
时间窗: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
次要结局
- assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold(Up to 60 months)
- assess the rate of patients with no filtering bleb(Up to 60 months)
- Average number of adjunctive therapies and follow up visits(Up to 60 months)
- Evaluate surgical procedure(Day 0, day of surgery)
- Evaluate implant and surgical procedure safety(up to 60 months)
- Compare clinical success rate(Up to 60 months)
- assess rate of patients with a reduction in post-op IOP with or without combined treatments(Up to 60 months)
- assess the mean and median reduction in IOP(Up to 60 months)
- assess the rate of patients without medical treatment for glaucoma(Up to 60 months)
- average rate of IOP reduction(Up to 60 months)
- assess the rate of patients with a reduction of IOP post-operatively(Up to 60 months)
- assess IOP stability(Up to 60 months)
- Assess patient satisfaction(Up to 60 months)
- Assess changes in quality of life(Up to 60 months)
- Follow the progression of glaucoma and potential complications(Up to 60 months)