Health TrialsbyHealthPanel

Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

ConditionKeratoconus, Unstable
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorKent Wellish MD

About this trial

Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of central or inferior corneal steepening

Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

Fleischer ring

Vogt's striae

Disqualifiers

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.

History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Riboflavin

    Drug

    Corneal cross linking achieved by combination of Riboflavin and ultraviolet light

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Cross linking treatment for corneal thinningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Best Corrected Visual Acuity

Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff

Time frame
Baseline and 1 year
2

Change in Uncorrected Visual Acuity

Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician

Time frame
Baseline and 1 year
3

Occurrence of Adverse Events

Surgeon notes any occurrence of adverse events related to the treatment

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kent Wellish MD

Lead sponsor

Wellish Vision Institute

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: