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Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL) (CXL)

Primary Purpose

Keratoconus, Unstable

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Riboflavin
Sponsored by
Kent Wellish MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus, Unstable

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of central or inferior corneal steepening
  • Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
  • Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
  • Fleischer ring
  • Vogt's striae
  • Decentered corneal apex
  • Munson's sign
  • Rizutti's sign
  • Apical corneal scarring consistent with Bowman's breaks
  • Scissoring of the retinoscopic reflex
  • Crab-claw appearance on topography
  • Steepest keratometry (Kmax) value > or = 47.20 D
  • I-S keratometry difference > 1.5 D on the Orbscan map
  • Posterior corneal elevation > 16 microns
  • Thinnest corneal point < 485 microns
  • Post LASIK/PRK stromal ablation depth < 300 microns or expected keratometry > 47.2 D, or post-PRK/SMILE in keratoconus suspect eyes
  • Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of > 25% corneal thickness
  • Contact Lens Wearers Only:
  • Removal of contact lenses for the required period of time prior to the screening refraction:

Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear

  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

  • Eyes classified as either normal or atypical normal on the severity grading scheme
  • Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used.

  • 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 or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
    2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure
  • 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cross linking treatment for corneal thinning

    Arm Description

    Cornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light.

    Outcomes

    Primary Outcome Measures

    Change in Best Corrected Visual Acuity
    Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff
    Change in Uncorrected Visual Acuity
    Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician
    Occurrence of Adverse Events
    Surgeon notes any occurrence of adverse events related to the treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2021
    Last Updated
    May 21, 2021
    Sponsor
    Kent Wellish MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04731727
    Brief Title
    Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)
    Acronym
    CXL
    Official Title
    Safety and Effectiveness of the CCL Vario System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kent Wellish MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
    Detailed Description
    Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus, Unstable

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cross linking treatment for corneal thinning
    Arm Type
    Experimental
    Arm Description
    Cornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light.
    Intervention Type
    Drug
    Intervention Name(s)
    Riboflavin
    Other Intervention Name(s)
    Ultra violet light
    Intervention Description
    Corneal cross linking achieved by combination of Riboflavin and ultraviolet light
    Primary Outcome Measure Information:
    Title
    Change in Best Corrected Visual Acuity
    Description
    Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff
    Time Frame
    Baseline and 1 year
    Title
    Change in Uncorrected Visual Acuity
    Description
    Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician
    Time Frame
    Baseline and 1 year
    Title
    Occurrence of Adverse Events
    Description
    Surgeon notes any occurrence of adverse events related to the treatment
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Presence of central or inferior corneal steepening Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: Fleischer ring Vogt's striae Decentered corneal apex Munson's sign Rizutti's sign Apical corneal scarring consistent with Bowman's breaks Scissoring of the retinoscopic reflex Crab-claw appearance on topography Steepest keratometry (Kmax) value > or = 47.20 D I-S keratometry difference > 1.5 D on the Orbscan map Posterior corneal elevation > 16 microns Thinnest corneal point < 485 microns Post LASIK/PRK stromal ablation depth < 300 microns or expected keratometry > 47.2 D, or post-PRK/SMILE in keratoconus suspect eyes Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of > 25% corneal thickness Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear Signed written informed consent Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: Eyes classified as either normal or atypical normal on the severity grading scheme Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.) Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tony F Sterrett
    Phone
    702-932-4265
    Email
    tsterrett@wellish.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kent L Wellish, MD
    Phone
    702-339-2020
    Email
    klwellish@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kent L Wellish, MD
    Organizational Affiliation
    Wellish Vision Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Unidentifiable patient data and pre- and post-op results will be shared.

    Learn more about this trial

    Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

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