Retinal Detachment Clinical Trial
— RESIGHTOfficial title:
Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
To evaluate the intra-operative efficacy of a new intra-operative viewing device.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures - Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction). - Both vitrectomy-only and combined phaco-vitrectomy surgeries - General or local anesthesia, or combination Exclusion Criteria: - Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form - Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP. - Repeat vitrectomy surgery |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitaire Ziekenhuizen Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultra Wide Field lens View Angle evaluation | Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation) | during surgery | |
Primary | Ultra Wide Field lens Condensation evaluation | Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation) | during surgery | |
Primary | Wide Angle lens Condensation evaluation | Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation) | during surgery | |
Primary | Illumination appearance evaluation | Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower) | during surgery | |
Primary | Color appearance evaluation | color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors ) | during surgery |
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