NCT05269680

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

February 8, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

February 8, 2022

Last Update Submit

February 26, 2025

Conditions

Open Angle Glaucoma

Keywords

Open Angle GlaucomaMinimally Invasive Glaucoma SurgeryMINIject

Outcome Measures

Primary Outcomes (3)

  • QoL

    quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18

    2 years after surgery

  • ease of use

    the usability of the device will be defined by use of a surgeon questionnaire.

    1 day

  • 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitatsklinik fur Augenheilkunde Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Florence Defresne

CONTACT

+32 10 771 676florence.defresne@istartmed.com

Pascale Ducloux

CONTACT

+32 10 771 676pascale.ducloux@istartmed.com

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)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 28, 2025

Record last verified: 2025-02

Locations

CH(1)