Zeiss RESIGHT Disposable Lenses Evaluation Study (RESIGHT)

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Detachment; Macular Holes; Vitreomacular Traction; Macular Pucker
• Intervention / Treatment: Device: ZEISS disposable

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingeborg Vriens, SC; Phone Number: 003216342229; Email: ingeborg.vriens@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitaire Ziekenhuizen Leuven
      • Contact: Ingeborg Vriens; Phone Number: +32 16 342229; Email: ingeborg.vriens@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; primary vitrectomy surgery for retinal detachment	Device: ZEISS disposable; a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.
Active Comparator: group 2; macular surgery: pucker, vitreomacular traction or macular hole	Device: ZEISS disposable; a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Peter Stalmans, PhD, MD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment; Epiretinal Membrane
• Other Study ID Numbers: S67415

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No