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

August 8, 2022 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

Recruiting

Conditions

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 (Anticipated)

750

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Universitatsklinik fur Augenheilkunde Inselspital
        • Contact:
          • Milko Iliev, Prof.

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

Genders Eligible for Study

All

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

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 (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2026

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)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

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.

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