A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL WITH ONE COHORT ANALYSING THE EFFICACY AND SAFETY OF MINIJECT IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visit
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of the MINIject system in patients diagnosed with open angle glaucoma uncontrolled by topical hypotensive medications. MINIject is intended to be used to reduce the intraocular pressure (IOP) by channelling aqueous humour out of the anterior chamber to a sub-scleral location, thus enhancing the physiological uveoscleral outflow.
MINIject is indicated in adult, male and female patients diagnosed with primary or secondary open angle glaucoma, and where the progression of glaucoma is not adequately controlled by topical hypotensive medication(s).
MINIject is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant and a Delivery Tool. The Delivery Tool is configured for inserting the implant into the sub-scleral location through an ab-interno minimally-invasive approach.
The delivery tool is single-use. The intervention is to be performed as stand-alone surgery.
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
- •â€¢ Males or females, 18 years of age or older.
- •â€¢ Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •â€¢ Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
- •â€¢ 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 ≤ 35mmHg in the study eye at screening and baseline visits.
- •â€¢ Patients must be willing and able to return for scheduled study-related examinations.
- •â€¢ Patients must provide written informed consent.
排除标准
- •â€¢ Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
- •â€¢ 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.
- •â€¢ Neovascular glaucoma in the study eye.
- •â€¢ Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.
- •â€¢ 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 screening visit.
- •â€¢ Visual field defect in the 10-degree central field in the study eye.
- •â€¢ Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery.
- •â€¢ Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •â€¢ Pre-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.
- •â€¢ Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
- •â€¢ Evidence of crystalline lens subluxation or luxation in the study eye.
- •â€¢ Clinically significant intra-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.
- •â€¢ Presence of silicone oil in the study eye.
- •â€¢ Patients treated with systemic acetazolamide within 3 days before screening.
- •â€¢ Patient with poor vision (LogMar score: +1.0) in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.
- •â€¢ Only for women of childbearing potential: positive urine pregnancy test at screening.
- •â€¢ Individuals under tutorship or trusteeship.
结局指标
主要结局
Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visit
时间窗: 6 months
次要结局
- Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated(diurnal IOP at screening visit.)