Collagen Cross-linking in Keratoconus
Primary Purpose
Keratoconus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Custom Corneal Collagen Cross-Linking
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus (KCN), Optical Coherence Tomography (OCT), Collagen Cross-linking (CXL)
Eligibility 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
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
OCT-guided custom laser CXL
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03760432
First Posted
November 28, 2018
Last Updated
September 22, 2022
Sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT03760432
Brief Title
Collagen Cross-linking in Keratoconus
Official Title
Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus (KCN), Optical Coherence Tomography (OCT), Collagen Cross-linking (CXL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
OCT-guided custom laser CXL
Intervention Type
Procedure
Intervention Name(s)
Laser Custom Corneal Collagen Cross-Linking
Intervention Description
Preoperative 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.
Primary Outcome Measure Information:
Title
Improvement in best spectacle-corrected visual acuity after laser custom CXL
Description
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 procedure
Secondary Outcome Measure Information:
Title
Determine CXL demarcation line depth
Description
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 procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denzil Romfh, OD
Phone
503-494-4351
Email
romfhd@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Humberto Martinez, COT
Phone
503-494-7712
Email
martinhu@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Huang, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denzil Romfh, OD
Phone
503-494-4351
Email
romfhd@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Humberto Martinez, COT
Phone
503-494-7712
Email
martinhu@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
Collagen Cross-linking in Keratoconus
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