Zeiss RESIGHT Disposable Lenses Evaluation Study

NCT05860985 | Completed

• 1 other identifier: S67415
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Detachment; Macular Pucker; Macular Holes; Vitreomacular Traction

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

group 1

ACTIVE COMPARATOR

primary vitrectomy surgery for retinal detachment

Device: ZEISS disposable

group 2

ACTIVE COMPARATOR

macular surgery: pucker, vitreomacular traction or macular hole

Device: ZEISS disposable

Interventions

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.

group 1; group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Retinal Detachment; Epiretinal Membrane; Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Peter Stalmans, PhD, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 16, 2023
• Study Start: April 11, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 31, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

BE (1)