Actively Recruiting
Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
Led by Oregon Health and Science University · Updated on 2025-09-09
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a procedure called Laser Custom Corneal Collagen Cross-linking (CXL) to treat keratoconus, an eye condition affecting the cornea. The study evaluates the use of Optical Coherence Tomography (OCT), a non-contact imaging method that measures scar depth, cloudiness, and corneal thinning, to guide laser settings during corneal smoothing. The goal is to see how OCT guidance affects vision improvement and corneal healing after the procedure. The treatment involves using OCT measurements before surgery to help set laser depth for smoothing the cornea and removing opacities while keeping enough corneal tissue intact. After laser treatment, patients receive either mitomycin-C (MMC), a substance that reduces corneal haze, or saline solution according to their assigned group. Then, the standard FDA-approved CXL procedure is performed. This study compares the effects of these steps to assess direct and indirect laser impacts. Participants will be monitored for at least six months after the laser custom CXL procedure. Researchers will measure improvement in best spectacle-corrected visual acuity and assess the depth of the CXL demarcation line one month after treatment. During the study, patients will have OCT imaging and other eye examinations to track healing and vision changes. The research aims to better understand how OCT guidance influences outcomes in keratoconus treatment.
CONDITIONS
Brief Title
Collagen Cross-linking in Keratoconus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of keratoconus
- Minimum corneal thickness of 410 microns
- Age 18 years or older
You will not qualify if you...
- Inability to maintain fixation for OCT imaging
- Inability to commit to required study visits
- Inability to give informed consent
- Eyes with retinal diseases, glaucoma, or other eye conditions that may limit visual outcome
- Mature cataracts limiting visual potential to worse than 20/40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with immediate post-operative care
Participants undergo OCT-guided custom laser corneal collagen cross-linking surgery, including preoperative OCT measurements, laser ablation with adjunctive MMC or saline application, followed by the corneal collagen cross-linking procedure.
1 surgery visit and several immediate post-operative assessments
Duration - 6 months
Participants are monitored for recovery and visual acuity improvements, including assessment of the CXL demarcation line depth and best spectacle-corrected visual acuity.
Multiple follow-up visits including assessments at 1 month and 6 months post-procedure
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
D
Denzil Romfh, OD
H
Humberto Martinez, COT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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