McNeel Eye Center Corneal Crosslinking Study

Last updated: April 3, 2025
Sponsor: McNeel Eye Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Eye Disease

Vision Loss

Treatment

Crosslinking using UV light of two different fluence rates

Clinical Study ID

NCT02921009
MEC CxL Transepithelial
  • Ages 15-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females between the ages of 15 and 50 with keratoconus diagnosedtopographically with or without other corneal ectatic disease.

Exclusion

Exclusion Criteria:

  • Prior corneal transplantation, pregnancy, inability or unwillingness to adhere tofollow up protocol.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Crosslinking using UV light of two different fluence rates
Phase:
Study Start date:
September 01, 2016
Estimated Completion Date:
December 31, 2025

Study Description

Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Connect with a study center

  • McNeel Eye Center

    Boise, Idaho 83713
    United States

    Site Not Available

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