As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
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
320
each participant receives an implant Miniject and are followed during 2 years
Medizinische Universität Graz
Graz, Austria
Universitätsklinik für Augenheilkunde u. Optometrie
Salzburg, Austria
Unexpected incidents and/or serious reportable incidents
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.
Time frame: From enrollment up to 2 years after surgery (study completion)
Surgeon assessment of Device Usability
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.
Time frame: The surgery day
Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire
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.
Time frame: Baseline, 12 and 24 months
IOP measurement
IOP measurements at each follow-up visit over time and changes compared to baseline
Time frame: Baseline, 1 day and 1, 3, 6, 12 and 24 months
Ocular medication use
Ocular medication use at each follow-up visit and changes compared to baseline
Time frame: From enrollment through 2 years after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinik für Augenheilkunde und Optometrie
Vienna, Austria
Knappschaftskrankenhaus University Hospital
Bochum, Germany
International Innovative Ophtalmochirurgie GbR,
Düsseldorf, Germany
Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde
Hamburg, Germany
Augenzentrum ONE/Nordblick Augenklinik Bellevue
Kiel, Germany
Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde
Lübeck, Germany
Universitätsklinikum Ulm / Augenklinik
Ulm, Germany
Glaucoma Research Center, Swiss Visio, Montchoisi clinic
Lausanne, Switzerland
...and 5 more locations
Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale
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.
Time frame: From enrollment until 2 years post-surgery
BCVA testing
Best Corrected Visual Acuity (BCVA) outcomes at each follow-up visit and changes compared to baseline
Time frame: Baseline, 1, 3, 6, 12, 24 months
Visual field
Visual field outcomes at each follow-up visit and changes compared to baseline
Time frame: Baseline, 6, 12 and 24 months
Additional ocular surgery post-implantation
Additional ocular surgery post-implantation will be registered through the study
Time frame: From surgery until 2 years post-surgery