Actively Recruiting
A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Led by iSTAR Medical · Updated on 2025-02-28
300
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and performance of the MINIject glaucoma implant in patients with open-angle glaucoma or ocular hypertension not controlled by topical hypotensive medications. This observational study includes patients who previously received the MINIject implant in an earlier clinical trial and aims to follow them for up to five years after implantation to monitor outcomes. The study involves annual follow-up visits from two to five years post-implantation. During these visits, standard eye examinations will be performed, including measuring intraocular pressure, examining the fundus, ocular imaging, and checking for any eye-related adverse events. The implant was placed in a prior study and is not part of the current study procedures. Participants will undergo regular ophthalmologic assessments to track the implant's safety and performance over time. The primary outcome measured is the proportion of patients experiencing serious device-related adverse events in the treated eye five years after implantation. Participants will provide informed consent and attend visits as scheduled to support comprehensive long-term monitoring.
CONDITIONS
Brief Title
MINIject Global Long-Term Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are followed for long-term safety and performance assessments of the MINIject glaucoma implant, including ophthalmologic examinations and ocular imaging.
Annual visits for up to 3 years
Trial Site Locations
Total: 9 locations
1
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
Actively Recruiting
2
Center Hospotalier Universitaire Genoble Alpes
Grenoble, France, 38043
Active, Not Recruiting
3
Hopital de la Croix-Rousse
Lyon, France, 69417
Active, Not Recruiting
4
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany, 50937
Active, Not Recruiting
5
Universitätsklinikum Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Active, Not Recruiting
6
Klinikum der Universität München
München, Germany, 81377
Actively Recruiting
7
Maxivision Eye Hospital
Hyderabad, Telangana, India, 500034
Actively Recruiting
8
Panama Eye Center
Panama City, Panama
Active, Not Recruiting
9
Hospital Clínico San Carlos
Madrid, Spain
Active, Not Recruiting
Research Team
E
Esma Islamaj, PhD
P
Pascale Ducloux
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here