Theranostic Guided Riboflavin/UV-A Corneal Cross-linking

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

January 26, 2024

Study Completion Date

January 26, 2024

Conditions
Keratoconus
Interventions
DEVICE

Riboflavin/UV-A corneal cross-linking

Corneal cross-linking procedure is performed using the C4V CHROMO4VIS™ medical device equipped with theranostic software module in all participants. Participants will receive a single dose of the 0.22% riboflavin ophthalmic solution, RitSight™. Application of the riboflavin eye drop is done for 15 minutes for the epi-off CXL treatment and 20 minutes for the epi-on CXL treatment. Estimates of riboflavin concentration into the cornea are monitored by the C4V CHROMO4VIS™ system during the dosing phase of treatment. Once the pre-set dosing phase is completed, the C4V CHROMO4VIS™ system provides the Operator the access to the UV-A light irradiation of the cornea with 5.4 J/cm2 total energy dose (10 mW/cm2 for 9 min.) and 7.00 mm light beam diameter in all participants. Estimates of treatment efficacy by calculation of theranostic score are performed by the C4V CHROMO4VIS™ system during UV-A light irradiation.

Trial Locations (3)

50134

Azienda Ospedaliera Universitaria Careggi, Università di Firenze, Florence

88100

Azienda Ospedaliera Universitaria Mater Domini - Università Magna Graecia di Catanzaro, Catanzaro

98124

Azienda Ospedaliera Universitaria Policlinico G. Martino, Università di Messina, Messina

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

lead

Regensight

INDUSTRY