Zeiss RESIGHT Disposable Lenses Evaluation Study

• Sponsor: Universitaire Ziekenhuizen KU Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05860985
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 13.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment; Macular Pucker; Macular Holes; Vitreomacular Traction	Device: ZEISS disposable	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
• Actual Study Start Date: Apr 11, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. Ultra Wide Field lens Condensation evaluation [during surgery]

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

3. Wide Angle lens Condensation evaluation [during surgery]

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

4. Illumination appearance evaluation [during surgery]

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

5. Color appearance evaluation [during surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen KU Leuven

Investigators

• Principal Investigator: Peter Stalmans, PhD, MD, UZ Leuven

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 7, 2023

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen KU Leuven
• ClinicalTrials.gov Identifier: NCT05860985
• Other Study ID Numbers: S67415
• First Posted: May 16, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Detachment; Retinal Perforations; Epiretinal Membrane

Study Results

No Results Posted as of May 19, 2023