Zeiss RESIGHT Disposable Lenses Evaluation Study

Retinal Detachment Clinical Trial

— RESIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860985
• Other study ID #: S67415
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Ingeborg Vriens, SC
• Phone: 003216342229
• Email: ingeborg.vriens[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Holes
• Macular Pucker
• Retinal Detachment
• Retinal Perforations
• Vitreomacular Traction

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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