STAR-GLOBAL: MINIject Global Long-Term Follow-up Study

Sponsor

iSTAR Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04524416

Collaborator

(none)

300

Enrollment

Location

63.9

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	Device: Minimally invasive glaucoma surgery (MIGS)

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 5, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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