Actively Recruiting
STAR-LIFE: a Post-market Registry on MINIject for Open Angle Glaucoma
Led by iSTAR Medical · Updated on 2025-02-28
750
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on the MINIject device used in patients with open angle glaucoma. This observational registry aims to gather information about how the device is used, patient-reported outcomes, and its safety over a two-year period following surgery. The study is sponsored by iSTAR Medical to provide meaningful evidence about the device in everyday clinical settings. Participants are those who have been or will be implanted with the CE-marked MINIject device. The registry tracks patient experiences and device performance without altering standard medical care. The study focuses on three main goals: ease of use measured one day after surgery, quality of life assessed two years after surgery, and recording any treatment-related incidents during the two-year follow-up. During the study, participants will be monitored over two years after their surgery. Researchers will collect data on the usability of the device shortly after implantation and assess quality of life changes throughout the follow-up. Safety is closely watched by noting any treatment-related problems. Participants provide consent and their progress is observed in a real-life clinical context without additional interventions.
CONDITIONS
Brief Title
STAR-LIFE: a Post-market Registry on MINIject
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with open angle glaucoma
- Has been or will be implanted with the CE-marked MINIject device
- Able to give consent
You will not qualify if you...
- Eyes with angle closure glaucoma
- Eyes with traumatic, malignant, uveitic, neovascular glaucoma, or congenital anterior chamber angle anomalies
- Known intolerance or hypersensitivity to silicone
- Unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the MINIject device and receive immediate post-surgery care.
1 visit (in-person)
Duration - 2 years
Participants are monitored for device usability, patient reported outcomes, and safety over 2 years after surgery.
Regular follow-up visits up to 2 years
Trial Site Locations
Total: 1 location
1
Universitatsklinik fur Augenheilkunde Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
F
Florence Defresne
P
Pascale Ducloux
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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