Collagen Cross-linking in Keratoconus

NCT03760432 | Recruiting

• 2 other identifiers: 6612-CXLR01EY028755
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in best spectacle-corrected visual acuity after laser custom CXL

  The primary goal of the trial is to determine the extent of visual improvement after laser custom CXL compared to preoperative measurements. Vision will be checked at various time points, but the primary time point will be 6-months post-procedure.

  6 months after the CXL procedure

Secondary Outcomes (1)

• Determine CXL demarcation line depth

  1 month after the CXL procedure

Study Arms (1)

Surgery

EXPERIMENTAL

OCT-guided custom laser CXL

Procedure: Laser Custom Corneal Collagen Cross-Linking

Interventions

Laser Custom Corneal Collagen Cross-Linking PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of keratoconus
• Minimum corneal thickness of 410 microns

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• David Huang, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denzil Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Humberto Martinez, COT

CONTACT

503-494-7712; martinhu@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peterson Professor of Ophthalmology & Professor of Biomedical Engineering

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: June 20, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)