Zeiss RESIGHT Disposable Lenses Evaluation Study

Last updated: August 23, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Completed

Phase

N/A

Condition

Retina

Macular Degeneration

Treatment

ZEISS disposable

Clinical Study ID

NCT05860985
S67415
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate the intra-operative efficacy of a new intra-operative viewing device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures

  • Patients that are scheduled for primary vitrectomy surgery to treat retinaldetachment or macular disease (pucker, macular hole, vitreomacular traction).

  • Both vitrectomy-only and combined phaco-vitrectomy surgeries

  • General or local anesthesia, or combination

Exclusion

Exclusion Criteria:

  • Patient who do not have sufficient command of the Dutch language to read andunderstand the informed consent form

  • Any disorder, which in the investigator's opinion might jeopardise participant'ssafety or compliance with the CIP.

  • Repeat vitrectomy surgery

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: ZEISS disposable
Phase:
Study Start date:
April 11, 2023
Estimated Completion Date:
July 31, 2024

Study Description

This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.

Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.

Connect with a study center

  • Universitaire Ziekenhuizen Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

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