Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking

NACompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

June 1, 2024

Study Completion Date

June 5, 2024

Conditions
Keratoconus
Interventions
PROCEDURE

Customized crosslinking

"In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.~The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States)."

PROCEDURE

Standard crosslinking

"In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.~The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States)."

Trial Locations (3)

6229 HX

Maastricht University Medical Center (MUMC+), Maastricht

9713 GZ

University Medical Center Groningen, Groningen

3584 CX

University Medical Center Utrecht, Utrecht

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Maastricht University Medical Center

OTHER

NCT04532788 - Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking | Biotech Hunter | Biotech Hunter