Open Angle GlaucomaSTAR-LIFENCT05269680
STAR-LIFE: a Post-market Registry on MINIject
An observational study of Open Angle Glaucoma, run by iSTAR Medical at 15 sites in 4 countries.
Trial summary
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Implant Miniject
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 20 Jul 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient diagnosed with open angle glaucoma
Who may be able to join
- 18+ years
- diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
- able to give consent
Who cannot join
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany6 sites
Knappschaftskrankenhaus University Hospital
Bochum, 44892
International Innovative Ophtalmochirurgie GbR,
Düsseldorf, 40212
Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde
Hamburg, 22417
Augenzentrum ONE/Nordblick Augenklinik Bellevue
Kiel, 24251
Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde
Lübeck, 23538
Universitätsklinikum Ulm / Augenklinik
Ulm, 89070
United Kingdom5 sites
East Suffolk and North Essex NHS foundation trust
Colchester, CO4 5JL
Princess Alexandra Eye Pavilion, NHS Lothian
Edinburgh, EH3 9HA
Imperial College NHS Trust
London, NW1 5QH
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Maidstone and Tunbridge Wells NHS trust
Maidstone, ME16 9QQ
Austria3 sites
Medizinische Universität Graz
Graz, 8010
Universitätsklinik für Augenheilkunde u. Optometrie
Salzburg, A-5020
Universitätsklinik für Augenheilkunde und Optometrie
Vienna, 1090
Switzerland1 site
Glaucoma Research Center, Swiss Visio, Montchoisi clinic
Lausanne, 1006
About this study
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- Implant Miniject
- Keywords
- Open Angle Glaucoma, Minimally Invasive Glaucoma Surgery, MINIject
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant MinijectDevice
each participant receives an implant Miniject and are followed during 2 years
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to 2 years after surgery (study completion)
Secondary outcomes (8)
Surgeon assessment of Device Usability
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.
Measured: The surgery day
Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire
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.
Measured: Baseline, 12 and 24 months
IOP measurement
IOP measurements at each follow-up visit over time and changes compared to baseline
Measured: Baseline, 1 day and 1, 3, 6, 12 and 24 months
Ocular medication use
Ocular medication use at each follow-up visit and changes compared to baseline
Measured: From enrollment through 2 years after surgery
Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale
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.
Measured: From enrollment until 2 years post-surgery
BCVA testing
Best Corrected Visual Acuity (BCVA) outcomes at each follow-up visit and changes compared to baseline
Measured: Baseline, 1, 3, 6, 12, 24 months
Visual field
Visual field outcomes at each follow-up visit and changes compared to baseline
Measured: Baseline, 6, 12 and 24 months
Additional ocular surgery post-implantation
Additional ocular surgery post-implantation will be registered through the study
Measured: From surgery until 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start20 Jul 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269680
- Sponsor's protocol ID
- STAR-LIFE (ISM11)
- Acronym
- STAR-LIFE
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAR-LIFE: a Post-market Registry on MINIject
- ClinicalTrials.gov ID
- NCT05269680
- Acronym / sponsor ID
- STAR-LIFE / STAR-LIFE (ISM11)
- Conditions
- Open Angle Glaucoma
- Keywords
- Open Angle Glaucoma, Minimally Invasive Glaucoma Surgery, MINIject
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient diagnosed with open angle glaucoma
Key inclusion criteria (3 listed)
- 18+ years
- diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
- able to give consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant Minijecteach participant receives an implant Miniject and are followed during 2 years | Device | – |
Primary outcome
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.
8 secondary outcomes
Surgeon assessment of Device Usability
Time frame: The surgery day
Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire
Time frame: Baseline, 12 and 24 months
IOP measurement
Time frame: Baseline, 1 day and 1, 3, 6, 12 and 24 months
Ocular medication use
Time frame: 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
BCVA testing
Time frame: Baseline, 1, 3, 6, 12, 24 months
Visual field
Time frame: Baseline, 6, 12 and 24 months
Additional ocular surgery post-implantation
Time frame: From surgery until 2 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by iSTAR Medical at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United Kingdom, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected incidents and/or serious reportable incidents (time frame: From enrollment up to 2 years after surgery (study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.