N/A
Completed N=50
Theranostic Guided Riboflavin/UV-A Corneal Cross-linking
Source: ClinicalTrials.gov NCT05457647 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Validation of the Theranostic Scores — 91; 95 Percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Validation of the Theranostic Scores |
91; 95 | — |
| SECONDARY Corneal Topography |
-1.5 | <0.05 sig |
| SECONDARY Endothelial Cell Density |
-63 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
criteria for inclusion in the clinical trial are those currently referred to as the golden standard for the treatment of corneal cross-linking. The criterion to determine progression of keratoconus is based on providing at least one of the following evidences:
- at least two Placido disk corneal topography measurements showing at least +1.00 D steepening of the Kmax value in the last year or longer interval period.
- at least two manifest refraction measurements showing at least -0.50 D change in spherical equivalent refraction in the last year or longer interval period.
- at least two central corneal thickness (CCT) measurements showing at least -10 µm change in in the last year or longer interval period.
Exclusion Criteria
- Anterior corneal curvature steeper than 63 D;
- Corneal thickness thinner than 400 µm;
- Corneal scarring;
- Descemetocele;
- History of herpetic keratitis;
- Concomitant eye diseases;
- Inflammatory eye diseases;
- Glaucoma;
- Cataract;
- Nistagmus;
- Pregnancy;
- Breast feeding.
Data sourced from ClinicalTrials.gov (NCT05457647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.