Collagen Cross-linking in Keratoconus

Last updated: September 5, 2025
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Vision Loss

Treatment

Laser Custom Corneal Collagen Cross-Linking

Clinical Study ID

NCT03760432
6612-CXL
R01EY028755
  • Ages > 18
  • All Genders

Study Summary

Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly decreases corneal aberrations and improves vision. This study will use OCT-guided setting for the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess the affect on visual outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of keratoconus

  • Minimum corneal thickness of 410 microns

Exclusion

Exclusion Criteria:

  • Inability to maintain fixation for OCT imaging

  • Inability to commit to required study visits

  • Inability to give informed consent

  • Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that maylimit the visual outcome after surgery

  • Mature cataracts if found to limit visual potential to worse than 20/40

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Laser Custom Corneal Collagen Cross-Linking
Phase:
Study Start date:
June 20, 2018
Estimated Completion Date:
December 31, 2027

Study Description

In the U.S., CXL and topography-guided laser ablation were approved independently, but not together. Another variation in technique involves the use of mitomycin-C (MMC), which is effective in reducing corneal haze after the laser surface ablation. Use of MMC during the laser custom CXL was associated with better outcomes, but in separate trials that could not be directly compared. This study will use OCT measurements to evaluate the magnitudes of direct and indirect laser actions after the procedure.

Connect with a study center

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

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