CTRI/2021/02/030922进行中（未招募）不适用
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL ANALYSING THE EFFICACYAND SAFETY OF MINIJECT (MINI SO627) IN PATIENTS WITH OPEN ANGLEGLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS USING AMODIFIED SINGLE OPERATOR DELIVERY SYSTEM
iSTAR Medical SA1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年5月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to show a greater than 20% reduction in medicated diurnal IOP between baseline visit and diurnal IOP 6 months after surgery with or without the use of concomitant use of IOPâ€lowering medications.
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of the MINIject system (i.e. MINI SO627) in patients diagnosed with primary open angle glaucoma uncontrolled by topical hypotensive medications.
MINIject is intended to be used to reduce the intraocular pressure (IOP) by channeling aqueous humour out of the anterior chamber to a subâ€scleral location, thus enhancing the physiological uveoscleral outflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or females, 18 years of age or older.
- •2.Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •3.Grade 3 (open, 20â€35 degrees) or grade 4 (wide open, 35â€45 degrees) according to Shaffer Angle Grading System.
- •Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
- •Patients must be willing and able to return for scheduled studyâ€related examinations.
- •Patients must provide written informed consent.
排除标准
- •Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
- •Neovascular glaucoma in the study eye.
- •Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
- •Prior glaucoma surgery in the study eye.
- •Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed ≥ 90 days before baseline visit in the study eye.
- •Visual field defect in the 10â€degree central field in the study eye.
- •Any eye surgery that was performed < 90 days before baseline visit in the study eye.
- •Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
- •Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •Preâ€existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.
- •Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
- •Evidence of crystalline lens subluxation or luxation in the study eye.
- •Evidence of vitreous loss in the anterior chamber in the study eye.
- •Clinically significant intraâ€ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye.
- •Presence of silicone oil in the study eye.
- •Patients treated with systemic acetazolamide within 3 days before screening/baseline visit.
- •Patient with poor vision score: +1.0 in nonâ€study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.
- •Participation in any study involving an investigational drug or device within the past 3 months and planned participation to any other study during the present study.
- •Only for women of childbearing potential: positive blood pregnancy test at baseline visit.
- •Individuals under tutorship or trusteeship.
结局指标
主要结局
The primary objective of the study is to show a greater than 20% reduction in medicated diurnal IOP between baseline visit and diurnal IOP 6 months after surgery with or without the use of concomitant use of IOPâ€lowering medications.
时间窗: 6 months post surgery
次要结局
- 1.To test the absolute and relative (in %) reduction in medicated or unmedicated (without washout) diurnal IOP between baseline visit and medicated diurnal IOP at 12†and 24 months after surgery.(2.To assess the safety of the MINIject in terms of nature and severity of AE/SAE, ADE/SADE, DDs and UADEs. Data can be pooled with other trials to compare the safety of SODT and SODT to implant MINIject glaucoma implant.)
研究者
研究点 (1)
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