Zeiss RESIGHT Disposable Lenses Evaluation Study

Not Applicable

Completed

• Conditions: Vitreomacular Traction; Retinal Detachment; Macular Pucker; Macular Holes
• Interventions: Device: ZEISS disposable

• Registration Number: NCT05860985
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-04-11
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-16
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	ZEISS disposable	primary vitrectomy surgery for retinal detachment
group 2	ZEISS disposable	macular surgery: pucker, vitreomacular traction or macular hole

Primary Outcome Measures

Name	Time	Method
Ultra Wide Field lens View Angle evaluation	during surgery	Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)
Ultra Wide Field lens Condensation evaluation	during surgery	Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Wide Angle lens Condensation evaluation	during surgery	Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Illumination appearance evaluation	during surgery	Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Color appearance evaluation	during surgery	color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium