Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement in best spectacle-corrected visual acuity after laser custom CXL
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgery
OCT-guided custom laser CXL
Intervention: Laser Custom Corneal Collagen Cross-Linking (Procedure)
Outcomes
Primary Outcomes
Improvement in best spectacle-corrected visual acuity after laser custom CXL
Time Frame: 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 Outcomes
- Determine CXL demarcation line depth(1 month after the CXL procedure)
Investigators
David Huang
Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
Oregon Health and Science University