STAR-LIFE: a Post-market Registry on MINIject

NCT05269680 | Active Not Recruiting

• 1 other identifier: STAR-LIFE (ISM11)
• Study Type: observational
• Target: 320
• Locations: 4 countries
• Sites: 15

Brief Summary

As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

Conditions

Open Angle Glaucoma

Keywords

Open Angle Glaucoma; Minimally Invasive Glaucoma Surgery; MINIject

Outcome Measures

Primary Outcomes (1)

• Unexpected incidents and/or serious reportable incidents

  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 Outcomes (8)

• Surgeon assessment of Device Usability

  The surgery day

• Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire

  Baseline, 12 and 24 months

• IOP measurement

  Baseline, 1 day and 1, 3, 6, 12 and 24 months

• Ocular medication use

  From enrollment through 2 years after surgery

• Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale

  From enrollment until 2 years post-surgery

Interventions

Implant Miniject DEVICE

each participant receives an implant Miniject and are followed during 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient diagnosed with open angle glaucoma

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• iSTAR Medical: lead

Study Sites (15)

Medizinische Universität Graz

Graz, 8010, Austria

Location

Universitätsklinik für Augenheilkunde u. Optometrie

Salzburg, A-5020, Austria

Location

Universitätsklinik für Augenheilkunde und Optometrie

Vienna, 1090, Austria

Location

Knappschaftskrankenhaus University Hospital

Bochum, 44892, Germany

Location

International Innovative Ophtalmochirurgie GbR,

Düsseldorf, 40212, Germany

Location

Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde

Hamburg, 22417, Germany

Location

Augenzentrum ONE/Nordblick Augenklinik Bellevue

Kiel, 24251, Germany

Location

Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde

Lübeck, 23538, Germany

Location

Universitätsklinikum Ulm / Augenklinik

Ulm, 89070, Germany

Location

Glaucoma Research Center, Swiss Visio, Montchoisi clinic

Lausanne, 1006, Switzerland

Location

East Suffolk and North Essex NHS foundation trust

Colchester, CO4 5JL, United Kingdom

Location

Princess Alexandra Eye Pavilion, NHS Lothian

Edinburgh, EH3 9HA, United Kingdom

Location

Imperial College NHS Trust

London, NW1 5QH, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Maidstone and Tunbridge Wells NHS trust

Maidstone, ME16 9QQ, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 8, 2022
• Study Start: July 20, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

CH (1); DE (6); GB (5); AU (3)