N/A
N=50
Theranostic Guided Riboflavin/UV-A Corneal Cross-linking
Keratoconus
Bottom Line
View on ClinicalTrials.gov: NCT05457647 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Validation of the Theranostic Scores — 91; 95 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Riboflavin/UV-A corneal cross-linking (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regensight
- Primary completion
- Jan 2024
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 |
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.
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.