MINIject Global Long-Term Follow-up Study

Recruiting

• Conditions: Ocular Hypertension; Open Angle Glaucoma

• Registration Number: NCT04524416
• Lead Sponsor: iSTAR Medical

Brief Summary

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Detailed Description

The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient who received a MINIject glaucoma implant within a prior clinical study
• Patient continues to have MINIject implanted at the point of enrolment
• Patient must provide written informed consent to participate

Exclusion Criteria

• Individuals under tutorship or trusteeship
• Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with serious device-related adverse event in study eye	5 years post-implantation	The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation.

Trial Locations

Locations (9)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Clinica Oftalmologica del Caribe; 🇨🇴 Barranquilla, Colombia

Panama Eye Center; 🇵🇦 Panama City, Panama

Uniklinik Köln; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Maxivision Eye Hospital; 🇮🇳 Hyderabad, Telangana, India

Hopital de la Croix-Rousse; 🇫🇷 Lyon, France

Center Hospotalier Universitaire Genoble Alpes; 🇫🇷 Grenoble, France

Klinikum der Universität München; 🇩🇪 München, Germany

Universitätsklinikum Mainz; 🇩🇪 Mainz, Rheinland Pfalz, Germany