CTRI/2019/06/019564Completed未知
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL ANALYSING THE EFFECTIVENESS AND SAFETY OF MINIJECT (MINI SO627) IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS USING A SINGLE OPERATOR DELIVERY TOOL - ISM08
iSTAR Medical SA0 sites4 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 4
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
- •5. Patients must be willing and able to return for scheduled study-related examinations.
- •6. Patients must provide written informed consent.
Exclusion Criteria
- •1. 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.
- •2. Neovascular glaucoma in the study eye.
- •3. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
- •4. 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 ââ?°Â¥ 90 days before baseline visit in the study eye.
- •5. Visual field defect in the 10-degree central field in the study eye.
- •6. Any eye surgery that was performed ââ?°Â¥ 90 days before baseline visit in the study eye.
- •7. Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
- •8. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •9. 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.
- •10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
- •11. Evidence of crystalline lens subluxation or luxation in the study eye.
- •12. Evidence of vitreous loss in the anterior chamber in the study eye.
- •13. 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.
- •14. Presence of silicone oil in the study eye.
- •15. Patients treated with systemic acetazolamide within 3 days before screening/baseline visit.
- •16. Patient with poor vision score: +1.0 in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.
- •17. 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.
- •18. Only for women of childbearing potential: positive blood pregnancy test at baseline visit.
- •19. Individuals under tutorship or trusteeship.
Investigators
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