CTRI/2018/02/012240已完成未知
A Prospective, Open, Multicenter Clinical Trial analyzing the Effectiveness and Safety of MINIject-636 in Patients with Open Angle Glaucoma uncontrolled by Topical Hypotensive Medications
iSTAR Medical SA0 个研究点目标入组 15 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
- 15
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
- •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, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
- •4. Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21 mmHg ââ?°Â¤ IOP ââ?°Â¤ 35 mmHg in the study eye at screening and baseline visits.
- •5. Patient must be willing and able to return for scheduled study-related examinations.
- •6. Patient must provide written informed consent.
排除标准
- •1. Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
- •2. 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.
- •3. Neovascular glaucoma in the study eye.
- •4. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.
- •5. Prior eye surgery in the study eye within 90 days before screening visit.
- •6. Prior glaucoma surgery in the study eye, except patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye may be eligible if treatment performed ââ?°Â¥ 90 days before screening visit.
- •7. Visual field defect in the 10 degree central field in the study eye.
- •8. Anticipated need for ocular surgery or retinal laser procedure in the study eye in the 12 months following surgery.
- •9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
- •11. 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.
- •12. Evidence of crystalline lens subluxation or luxation in the study eye.
- •13. Evidence of vitreous loss in the anterior chamber in the study eye.
- •14. 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.
- •15. Presence of silicone oil in the study eye.
- •16. Patients treated with systemic acetazolamide within 3 days before screening visit.
- •17. Patients 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.
- •18. Participation in any study involving an investigational drug or device within the past 3 Months.
- •19. Only for women of childbearing potential: positive urine pregnancy test at screening.
- •20. Individuals under tutorship or trusteeship.
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