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OpenTrials
Completed

NCT Number: NCT05860985

Zeiss RESIGHT Disposable Lenses Evaluation Study

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

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Key information

Conditions

Retinal Detachment Epiretinal Membrane Eye Diseases Macular Holes Macular Pucker Retinal Diseases Retinal Perforations Vitreomacular Traction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZEISS disposable

Device

a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.

Primary outcomes

  1. Ultra Wide Field lens View Angle evaluation

    Time frame: during surgery

    Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)

  2. Ultra Wide Field lens Condensation evaluation

    Time frame: during surgery

    Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)

  3. Wide Angle lens Condensation evaluation

    Time frame: during surgery

    Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)

  4. Illumination appearance evaluation

    Time frame: during surgery

    Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)

  5. Color appearance evaluation

    Time frame: during surgery

    color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study

Acronym: RESIGHT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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