Long-term follow-up for patients with MINIject glaucoma implants
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
This study is looking at how safe and effective the MINIject glaucoma implant is for people with open-angle glaucoma who haven't had enough control with eye drops, by following them for up to 5 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | iSTAR Medical Industry-sponsored |
| Locations | 9 sites (Barranquilla and 8 other locations) |
| Trial ID | NCT04524416 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term safety and performance of the MINIject glaucoma implant in patients with open-angle glaucoma who have not achieved adequate control with topical medications. Participants who were previously implanted with the device will be followed for up to 5 years, with annual assessments including intraocular pressure measurements and ocular examinations. The study aims to gather data on the effectiveness and safety of this minimally invasive glaucoma surgery approach over an extended period.
Who should consider this trial
Good fit: Ideal candidates are patients who have previously received a MINIject glaucoma implant and are willing to participate in long-term follow-up assessments.
Not a fit: Patients who have not received a MINIject implant or those who are unable to comply with study visit requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term efficacy and safety of the MINIject implant, potentially improving treatment options for patients with glaucoma.
How similar studies have performed: Other studies on minimally invasive glaucoma surgeries have shown promising results, indicating that this approach may be effective, though the specific long-term outcomes of the MINIject implant are still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barranquilla and 8 other locations
- Clinica Oftalmologica del Caribe — Barranquilla, Colombia (Recruiting)
- Center Hospotalier Universitaire Genoble Alpes — Grenoble, France (Active_not_recruiting)
- Hopital de la Croix-Rousse — Lyon, France (Active_not_recruiting)
- Uniklinik Köln — Cologne, North Rhine-Westphalia, Germany (Active_not_recruiting)
- Universitätsklinikum Mainz — Mainz, Rhineland-Palatinate, Germany (Active_not_recruiting)
- Klinikum der Universität München — München, Germany (Recruiting)
- Maxivision Eye Hospital — Hyderabad, Telangana, India (Recruiting)
- Panama Eye Center — Panama City, Panama (Active_not_recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Active_not_recruiting)
Study contacts
- Study coordinator: Esma Islamaj, PhD
- Email: esma.islamaj@istarmed.com
- Phone: +32 10 77 12 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.