MINIject Global Long-Term Follow-up Study (STAR-GLOBAL)

I

iSTAR Medical

Status

Enrolling

Conditions

Open Angle Glaucoma
Ocular Hypertension

Treatments

Device: Minimally invasive glaucoma surgery (MIGS)

Study type

Observational

Funder types

Industry

Identifiers

NCT04524416
STAR-GLOBAL (ISM09)

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial contacts and locations

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Central trial contact

Pascale Ducloux; Esma Islamaj, PhD

Data sourced from clinicaltrials.gov

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