STAR-LIFE: a Post-market Registry on MINIject (STAR-LIFE)

June 11, 2026 updated by: iSTAR Medical
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Medizinische Universität Graz
      • Salzburg, Austria, A-5020
        • Universitätsklinik für Augenheilkunde u. Optometrie
      • Vienna, Austria, 1090
        • Universitätsklinik für Augenheilkunde und Optometrie
  • Germany
      • Bochum, Germany, 44892
        • Knappschaftskrankenhaus University Hospital
      • Düsseldorf, Germany, 40212
        • International Innovative Ophtalmochirurgie GbR,
      • Hamburg, Germany, 22417
        • Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde
      • Kiel, Germany, 24251
        • Augenzentrum ONE/Nordblick Augenklinik Bellevue
      • Lübeck, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde
      • Ulm, Germany, 89070
        • Universitätsklinikum Ulm / Augenklinik
  • Switzerland
      • Lausanne, Switzerland, 1006
        • Glaucoma Research Center, Swiss Visio, Montchoisi clinic
  • United Kingdom
      • Colchester, United Kingdom, CO4 5JL
        • East Suffolk and North Essex NHS foundation trust
      • Edinburgh, United Kingdom, EH3 9HA
        • Princess Alexandra Eye Pavilion, NHS Lothian
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, NW1 5QH
        • Imperial College NHS Trust
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone and Tunbridge Wells NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient diagnosed with open angle glaucoma

Description

Inclusion Criteria:

  • 18+ years
  • diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
  • able to give consent

Exclusion Criteria:

  • eyes with angle closure glaucoma
  • eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
  • patients with known intolerance or hypersensitivity to silicone
  • patients unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unexpected incidents and/or serious reportable incidents
Time Frame: From enrollment up to 2 years after surgery (study completion)
Collection of incidents (nature (ocular or non-ocular), number and severity) throughout the study. The number of unexpected incidents and the number of individuals presenting at least one event will be reported.
From enrollment up to 2 years after surgery (study completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon assessment of Device Usability
Time Frame: The surgery day
The Device usability will be assessed by the surgeon using a study-specific usability questionnaire evaluating device preparation, handling, and use during surgery. Questionnaire items may include categorical ratings, ordinal scales, and free-text comments, as applicable.
The surgery day
Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire
Time Frame: Baseline, 12 and 24 months
Quality of life will be assessed using the Symptom and Health Problem Checklist (SHPC-18) questionnaire, an 18 item instrument for patients treated for glaucoma. The questionnaire includes two domains: local eye symptoms (7 items) and Visual function problems (11 items). Each item is scored and a total "bothersome score" is calculated by summing all 18 items (range 0-1800) and dividing by 18, resulting in a final score ranging from 0 to 100. Higher scores indicate greater symptom burden and worse quality of life. Change from baseline will be evaluated at 12 and 24 months.
Baseline, 12 and 24 months
IOP measurement
Time Frame: Baseline, 1 day and 1, 3, 6, 12 and 24 months
IOP measurements at each follow-up visit over time and changes compared to baseline
Baseline, 1 day and 1, 3, 6, 12 and 24 months
Ocular medication use
Time Frame: From enrollment through 2 years after surgery
Ocular medication use at each follow-up visit and changes compared to baseline
From enrollment through 2 years after surgery
Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale
Time Frame: From enrollment until 2 years post-surgery
At each follow-up visit, the investigator will assess the presence and severity of ocular symptoms (including blurred vision, glare, halos, dryness, foreign body sensation, and other reported symptoms) using the categories: absent, mild, moderate, severe, very severe, or unknown. Changes from baseline will be evaluated.
From enrollment until 2 years post-surgery
BCVA testing
Time Frame: Baseline, 1, 3, 6, 12, 24 months
Best Corrected Visual Acuity (BCVA) outcomes at each follow-up visit and changes compared to baseline
Baseline, 1, 3, 6, 12, 24 months
Visual field
Time Frame: Baseline, 6, 12 and 24 months
Visual field outcomes at each follow-up visit and changes compared to baseline
Baseline, 6, 12 and 24 months
Additional ocular surgery post-implantation
Time Frame: From surgery until 2 years post-surgery
Additional ocular surgery post-implantation will be registered through the study
From surgery until 2 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iSTAR Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-LIFE (ISM11)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma

Clinical Trials on Implant Miniject

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe