Improving vision in keratoconus using laser collagen cross-linking
Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
NA · Oregon Health and Science University · NCT03760432
This study is testing a new way to use laser treatment to improve vision in people with keratoconus by using special imaging to make the procedure more precise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University (other) |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03760432 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Optical Coherence Tomography (OCT) to guide laser custom corneal collagen cross-linking (CXL) in patients with keratoconus. By measuring corneal thickness and other parameters, the study aims to enhance the precision of the CXL procedure, which is designed to reduce corneal aberrations and improve visual outcomes. The research will evaluate the effectiveness of this approach in comparison to traditional methods, particularly focusing on the impact of using mitomycin-C during the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with keratoconus who have a minimum corneal thickness of 410 microns.
Not a fit: Patients with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcomes will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved vision and reduced corneal haze for patients with keratoconus.
How similar studies have performed: Previous studies have shown promising results with collagen cross-linking techniques, but this specific approach using OCT guidance is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: David Huang, MD, PhD — Oregon Health and Science University
- Study coordinator: Denzil Romfh, OD
- Email: romfhd@ohsu.edu
- Phone: 503-494-4351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratoconus, Optical Coherence Tomography, Collagen Cross-linking