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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05860985
Other study ID # S67415
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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