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Active, Not Recruiting

NCT Number: NCT05269680

STAR-LIFE: a Post-market Registry on MINIject

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Graz, Graz, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implant Miniject

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. Visual field

    Time frame: Baseline, 6, 12 and 24 months

    Visual field outcomes at each follow-up visit and changes compared to baseline

  8. 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

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Acronym: STAR-LIFE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 8, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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