The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

November 13, 2018

Primary Completion Date

August 1, 2021

Study Completion Date

September 1, 2022

Conditions
Fuchs DystrophyEndothelial Corneal DystrophyBullous KeratopathyVision Disorders
Interventions
DEVICE

intraoperative optical coherence tomography (iOCT)

"The OCT technology is fully integrated in a conventional ophthalmic surgical microscope (Zeiss LUMERA 700 platform). The OCT consists of A-scans (length/thickness) and B-scans (X-Y plane) to create the three dimensional image. Alternatively C-scans (3D cube scans) are available. All scans are non-invasive. The surgeon can continue surgery whilst using the iOCT and view a live image projected in the binocular or on the external screen and the video stream can be recorded as well.~The iOCT features are controlled using the foot paddle and the images are recorded on device. Investigations will be performed in a standardized matter: iOCT imagery and cube-scans after graft insertion, air injection, and the end of surgery."

Trial Locations (3)

Unknown

Universiteitsziekenhuis Leuven, Leuven

Maastricht University Hospital, Maastricht

University Medical Center Utrecht, Utrecht

All Listed Sponsors
collaborator

Maastricht University Medical Center

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Carl Zeiss Surgical GmbH

INDUSTRY

lead

UMC Utrecht

OTHER

NCT03763721 - The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation | Biotech Hunter | Biotech Hunter