At a glance
ClinicalIndex Comparison Record- ✓At least one evidence of keratoconus progression in the past year or longer: ≥+1.00 D steepening of Kmax on Placido disk topography, OR ≥−0.50 D change in spherical equivalent refraction on manifest refraction, OR ≥−10 µm change in central corneal thickness (CCT).
- ✕Anterior corneal curvature steeper than 63 D.
- ✕Corneal thickness thinner than 400 µm.
- ✕Corneal scarring.
- ✕Descemetocele.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Theranostic Guided Riboflavin/UV-A Corneal Cross-linking for Treatment of Keratoconus
In Brief
A clinical study evaluating Riboflavin/UV-A corneal cross-linking for Keratoconus. Completed, enrolled 50 participants across 3 sites.
Detailed Summary
This is a clinical study consisting of a study arm to validate accuracy and precision of the combined use of theranostic imaging biomarkers, riboflavin score and theranostic score, to assess and predict efficacy of corneal cross-linking in flattening the corneal topography Kmax value at 12-months postoperatively. The objective of the study is to assess the performance of the theranostic software module (Research Use Only) of a CE marked (CE1936) UV-A medical device, C4V CHROMO4VIS™, in order to validate its use for theranostic-guided corneal cross-linking treatment of keratoconus and corneal ectasia. The study hypothesis is that theranostic-guided riboflavin/UV-A corneal cross-linking with the C4V CHROMO4VIS™ system is safe and can estimate treatment efficacy during operation, regardless of treatment protocol, i.e., either with or without epithelial removal.
Study Details
Timeline
Interventions
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.