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Zeiss RESIGHT Disposable Lenses Evaluation Study (RESIGHT)

Primary Purpose

Retinal Detachment, Macular Pucker, Macular Holes

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ZEISS disposable
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitaire Ziekenhuizen LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1

group 2

Arm Description

primary vitrectomy surgery for retinal detachment

macular surgery: pucker, vitreomacular traction or macular hole

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
July 18, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05860985
Brief Title
Zeiss RESIGHT Disposable Lenses Evaluation Study
Acronym
RESIGHT
Official Title
Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Macular Pucker, Macular Holes, Vitreomacular Traction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
primary vitrectomy surgery for retinal detachment
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
macular surgery: pucker, vitreomacular traction or macular hole
Intervention Type
Device
Intervention Name(s)
ZEISS disposable
Intervention Description
a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.
Primary Outcome Measure Information:
Title
Ultra Wide Field lens View Angle evaluation
Description
Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)
Time Frame
during surgery
Title
Ultra Wide Field lens Condensation evaluation
Description
Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Time Frame
during surgery
Title
Wide Angle lens Condensation evaluation
Description
Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Time Frame
during surgery
Title
Illumination appearance evaluation
Description
Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Time Frame
during surgery
Title
Color appearance evaluation
Description
color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingeborg Vriens, SC
Phone
003216342229
Email
ingeborg.vriens@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Stalmans, PhD, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingeborg Vriens
Phone
+32 16 342229
Email
ingeborg.vriens@uzleuven.be

12. IPD Sharing Statement

Learn more about this trial

Zeiss RESIGHT Disposable Lenses Evaluation Study

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