Open Angle Glaucoma
Conditions
Keywords
Open Angle Glaucoma, Minimally Invasive Glaucoma Surgery, MINIject
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.
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.
Interventions
DEVICEImplant Miniject
each participant receives an implant Miniject and are followed during 2 years
Sponsors
iSTAR Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unexpected incidents and/or serious reportable incidents | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon assessment of Device Usability | The surgery day | 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. |
| Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire | Baseline, 12 and 24 months | 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. |
| IOP measurement | Baseline, 1 day and 1, 3, 6, 12 and 24 months | IOP measurements at each follow-up visit over time and changes compared to baseline |
| Ocular medication use | From enrollment through 2 years after surgery | Ocular medication use at each follow-up visit and changes compared to baseline |
| Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale | From enrollment until 2 years post-surgery | 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. |
| BCVA testing | Baseline, 1, 3, 6, 12, 24 months | Best Corrected Visual Acuity (BCVA) outcomes at each follow-up visit and changes compared to baseline |
| Visual field | Baseline, 6, 12 and 24 months | Visual field outcomes at each follow-up visit and changes compared to baseline |
| Additional ocular surgery post-implantation | From surgery until 2 years post-surgery | Additional ocular surgery post-implantation will be registered through the study |
Countries
Austria, Germany, Switzerland, United Kingdom
Outcome results
None listed