Theranostic Guided Riboflavin/UV-A Corneal Cross-linking — ARGO  

Keratoconus Clinical Trial

Official title: Assessment of Theranostic Guided Riboflavin/UV-A Corneal Cross-linking for Treatment of Keratoconus

Status Completed

Clinical Trial Summary

This is a clinical study consisting of a study arm 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.

Clinical Trial Description

Keratoconus is a naturally-occurring ocular condition characterized by progressive thinning and steepening of the central cornea, resulting in corneal optical irregularities with increasing myopia, irregular astigmatism, corneal opacity and consequential loss of visual acuity. Riboflavin/UV-A corneal cross-linking is a procedure used to biomechanically stabilize the weak cornea in keratoconus and to slow down or halt the clinical progression of this disease. Theranostics is an emerging therapeutic paradigm that enables monitoring of image-guided therapy in clinic through the use of a theranostic module that makes use of real-time non-invasive molecular analysis of the tissue being treated to achieve optimal treatment outcomes in the management of disease.

The theranostic software module of the C4V CHROMO4VIS™ medical device is able to measure the concentration of riboflavin into the cornea during treatment (i.e., the riboflavin score) and to provide the surgeon with an objective assessment of treatment efficacy (i.e., the theranostic score).

The scope of this study is to validate the theranostic imaging biomarkers by assessing the change of corneal topography Kmax value at 1-year postoperatively. The 1-year follow-up is long enough to provide scientific evidence of the safety and efficacy of the theranostic UV-A medical device in question. A pre-operative examination will ensure that every interested and willing participant fulfils the inclusion criteria of this study. Post-operative examinations will be carried out after 1 week, 1 month, 3 months, 6 months and 12 months.

This is a multi-center clinical trial. Eligible participants will be stratified with allocation ratio 1:1 into either treatment protocol (EpiOn and EpiOFF Thera-CXL) using a computer-generated stratification plan with blocks. Two different blocks are created, which include eyes with Kmax steeper or flatter than 54.0 D to allocate patients with comparable baseline Kmax values in either treatment protocol. ;

Related Conditions & MeSH terms

• Keratoconus

• NCT number: NCT05457647
• Study type: Interventional
• Source: Regensight
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Completion date: January 26, 2024