CTRI/2018/02/012240
Completed
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 sites15 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iSTAR Medical SA
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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