Zeiss RESIGHT Disposable Lenses Evaluation Study

Universitaire Ziekenhuizen KU Leuven120 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Retinal Detachment Macular Pucker Macular Holes Vitreomacular Traction

Interventions

ZEISS disposableDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Ultra Wide Field lens View Angle evaluation

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

Time frame: during surgery

Ultra Wide Field lens Condensation evaluation

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

Time frame: during surgery

Wide Angle lens Condensation evaluation

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

Time frame: during surgery

Illumination appearance evaluation

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

Time frame: during surgery

Color appearance evaluation

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

Time frame: during surgery

Data from ClinicalTrials.gov

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