Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light
NCT ID: NCT05027295
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
170 participants
INTERVENTIONAL
2021-07-30
2025-07-31
Brief Summary
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Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.
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Detailed Description
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The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group. The secondary efficacy parameter is to determine if the two treatment groups are equivalent in their mean Kmax change at 6 months after treatment compared with baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous UVA
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time
riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.
Pulsed UVA
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time
riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes
Interventions
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riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.
riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes
Eligibility Criteria
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Inclusion Criteria
* Presence of central or inferior corneal steepening on the Pentacam map
* Axial topography consistent with keratoconus or post-surgical corneal ectasia
* Contact lens wearers only: removal of contact lenses for the required period of 1 week prior to the screening refraction
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria
* Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated
* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
2. Clinically significant scarring in the CXL treatment zone
* A history of chemical injury or delayed healing in the eye(s) to be treated
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
* Patients with current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
18 Years
ALL
Yes
Sponsors
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Cornea and Laser Eye Institute
OTHER
Responsible Party
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Principal Investigators
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Peter S Hersh, MD
Role: STUDY_DIRECTOR
Cornea and Laser Eye Institute, Hersh Vision Group
Locations
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Cornea and Laser Eye Institute, Hersh Vision Group
Teaneck, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACCEL-CXL-001
Identifier Type: -
Identifier Source: org_study_id
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