Collagen Cross-linking in Keratoconus
ConditionKeratoconus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of keratoconus
Minimum corneal thickness of 410 microns
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Laser Custom Corneal Collagen Cross-Linking
Procedure/SurgeryPreoperative 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SurgeryExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 months after the CXL procedureSecondary outcomes
1
Determine CXL demarcation line depth
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.
Time frame
1 month after the CXL procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov