A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
- Conditions
- Glaucoma
- Registration Number
- NCT07009236
- Lead Sponsor
- iSTAR Medical
- Brief Summary
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader 1 week Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (3)
Los Robles Vision d/b/a Centro Oftalmológico Robles
🇭🇳Santa Rosa de Copán, Honduras
Colchester General Hospital
🇬🇧Colchester, United Kingdom
St Thomas' Hospital
🇬🇧London, United Kingdom
Los Robles Vision d/b/a Centro Oftalmológico Robles🇭🇳Santa Rosa de Copán, Honduras