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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant Miniject | Device | each participant receives an implant Miniject and are followed during 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to 2 years after surgery (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The surgery day |
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Inclusion Criteria:
Exclusion Criteria:
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patient diagnosed with open angle glaucoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | 8010 | Austria | |||
| Universitätsklinik für Augenheilkunde u. Optometrie |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 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. |
| Baseline, 12 and 24 months |
| IOP measurement | IOP measurements at each follow-up visit over time and changes compared to baseline | 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 | From enrollment through 2 years after surgery |
| 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. | 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 | Baseline, 1, 3, 6, 12, 24 months |
| Visual field | Visual field outcomes at each follow-up visit and changes compared to baseline | Baseline, 6, 12 and 24 months |
| Additional ocular surgery post-implantation | Additional ocular surgery post-implantation will be registered through the study | From surgery until 2 years post-surgery |
| Salzburg |
| A-5020 |
| Austria |
| Universitätsklinik für Augenheilkunde und Optometrie | Vienna | 1090 | Austria |
| Knappschaftskrankenhaus University Hospital | Bochum | 44892 | Germany |
| International Innovative Ophtalmochirurgie GbR, | Düsseldorf | 40212 | Germany |
| Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde | Hamburg | 22417 | Germany |
| Augenzentrum ONE/Nordblick Augenklinik Bellevue | Kiel | 24251 | Germany |
| Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde | Lübeck | 23538 | Germany |
| Universitätsklinikum Ulm / Augenklinik | Ulm | 89070 | Germany |
| Glaucoma Research Center, Swiss Visio, Montchoisi clinic | Lausanne | 1006 | Switzerland |
| East Suffolk and North Essex NHS foundation trust | Colchester | CO4 5JL | United Kingdom |
| Princess Alexandra Eye Pavilion, NHS Lothian | Edinburgh | EH3 9HA | United Kingdom |
| Imperial College NHS Trust | London | NW1 5QH | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| Maidstone and Tunbridge Wells NHS trust | Maidstone | ME16 9QQ | United Kingdom |