Collagen Cross-linking in Keratoconus

Not Applicable

Recruiting

• Conditions: Keratoconus
• Interventions: Procedure: Laser Custom Corneal Collagen Cross-Linking

• Registration Number: NCT03760432
• Lead Sponsor: Oregon Health and Science University

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-20
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Laser Custom Corneal Collagen Cross-Linking	OCT-guided custom laser CXL

Primary Outcome Measures

Name	Time	Method
Improvement in best spectacle-corrected visual acuity after laser custom CXL	6 months after the CXL procedure	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.

Secondary Outcome Measures

Name	Time	Method
Determine CXL demarcation line depth	1 month after the CXL procedure	The study will use OCT imaging to measure the CXL demarcation line inside the entire optical zone. The demarcation line indicates the portion of corneal stroma being cross-linked. This helps determine to what extent the cornea is being strengthened.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States