Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

Launched by KENT WELLISH MD · Jan 28, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with certain corneal thinning conditions, specifically keratoconus and related issues. The treatment involves using Vitamin B2 (Riboflavin) along with UV light to see if it can help strengthen the cornea, which is the clear front part of the eye. The study is still in the early stages and hasn’t started recruiting participants yet.

To be eligible for this trial, participants must have specific signs of corneal thinning, such as a steepening shape of the cornea or certain other eye features that indicate keratoconus. They should also be willing to stop wearing contact lenses for a short time before the study starts. Participants can expect to receive the treatment and will need to attend follow-up visits to monitor their progress. It’s important to note that individuals with certain eye conditions, those who are pregnant, or those who have specific health issues may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Presence of central or inferior corneal steepening
• • Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• * Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
• • Fleischer ring
• • Vogt's striae
• • Decentered corneal apex
• • Munson's sign
• • Rizutti's sign
• • Apical corneal scarring consistent with Bowman's breaks
• • Scissoring of the retinoscopic reflex
• • Crab-claw appearance on topography
• • Steepest keratometry (Kmax) value \> or = 47.20 D
• • I-S keratometry difference \> 1.5 D on the Orbscan map
• • Posterior corneal elevation \> 16 microns
• • Thinnest corneal point \< 485 microns
• • Post LASIK/PRK stromal ablation depth \< 300 microns or expected keratometry \> 47.2 D, or post-PRK/SMILE in keratoconus suspect eyes
• • Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \> 25% corneal thickness
• * Contact Lens Wearers Only:
• * Removal of contact lenses for the required period of time prior to the screening refraction:
• • Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear
• • Signed written informed consent
• • Willingness and ability to comply with schedule for follow-up visits
• Exclusion Criteria:
• • Eyes classified as either normal or atypical normal on the severity grading scheme
• • Corneal pachymetry at the screening exam that is \< 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or \< 300 microns when the hypotonic riboflavin will be used.
• * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• • 1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
• • 2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure
• • Pregnancy (including plan to become pregnant) or lactation during the course of the study
• • A known sensitivity to study medications
• • Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
• • Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing