CTRI/2021/02/030922
Active, not recruiting
未知
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL ANALYSING THE EFFICACYAND SAFETY OF MINIJECT (MINI SO627) IN PATIENTS WITH OPEN ANGLEGLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS USING AMODIFIED SINGLE OPERATOR DELIVERY SYSTEM - ISM10
iSTAR Medical SA0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Sponsor
- iSTAR Medical SA
- Status
- Active, not recruiting
- 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, 20ââ?¬?35 degrees) or grade 4 (wide open, 35ââ?¬?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 studyââ?¬?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 10ââ?¬?degree central field in the study eye.
- •6\. Any eye surgery that was performed \< 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\. Preââ?¬?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.
Outcomes
Primary Outcomes
Not specified
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