CTRI/2018/03/012458已完成未知
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
iSTAR Medical SA0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Males or females, 18 years of age or older.
- •Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 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 <= 35mmHg in the study eye at screening and baseline visits.
- •Patients must be willing and able to return for scheduled study-related examinations.
- •Patients must provide written informed consent.
排除标准
- •Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
- •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.
- •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.
- •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.
- •Visual field defect in the 10-degree central field in the study eye.
- •Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery.
- •Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •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.
- •Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
- •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.
- •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 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.
- •Presence of silicone oil in the study eye.
- •Patients treated with systemic acetazolamide within 3 days before screening.
- •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.
- •Participation in any study involving an investigational drug or device within the past 3 months.
- •Only for women of childbearing potential: positive urine pregnancy test at screening.
- •Individuals under tutorship or trusteeship.
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