Recruiting

Collagen Cross-linking

Sponsor:

Oregon Health and Science University

Code:

NCT03760432

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laser Custom Corneal Collagen Cross-Linking

Study Details

Brief 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.

Conditions

Keratoconus

Study ID

NCT03760432

Start date

Jun 20, 2018

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of keratoconus
  • Minimum corneal thickness of 410 microns

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 may limit the visual outcome after surgery
  • Mature cataracts if found to limit visual potential to worse than 20/40

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgery

OCT-guided custom laser CXL

Interventions

Laser Custom Corneal Collagen Cross-Linking

Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for smoothing the anterior corneal surface and removing any present opacities. The surgeon uses the OCT data to plan treatment parameters while preserving at least 360 microns of residual corneal stroma using a phototherapeutic keratectomy procedure. After the laser procedure, adjunctive MMC or saline solution will be applied to the cornea in accordance with the group to which the treated eye is randomized. The CXL procedure is then performed following the FDA-approved CXL regimen by Avedro, Inc.

Primary outcome measure

  • Improvement in best spectacle-corrected visual acuity after laser custom CXL [ Time Frame: 6 months after the CXL procedure ]

Central Contacts and Locations

Central contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Keratoconus (KCN)
  • Optical Coherence Tomography (OCT)
  • Collagen Cross-linking (CXL)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-09.