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NCT05269680 Clinical Trial

STAR-LIFE: a Post-market Registry on MINIject

Open Angle Glaucoma Clinical Trial

— STAR-LIFE  

Official title:
STAR-LIFE: a Post-market Registry on MINIject

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05269680
Other study ID # STAR-LIFE (ISM11)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2022
Est. completion date July 1, 2026

Study information
Verified date August 2022
Source iSTAR Medical
Contact Florence Defresne
Phone +32 10 771 676
Email florence.defresne@istartmed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date July 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Universitatsklinik fur Augenheilkunde Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
iSTAR Medical

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary QoL quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18 2 years after surgery
Primary ease of use the usability of the device will be defined by use of a surgeon questionnaire. 1 day
Primary Number of participants with treatment-related incidents collection of incidences (nature (ocular or non-ocular), number and severity) throughout the study up to 2 years after surgery (study completion)
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