search
Back to results

Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
administration of riboflavin for epi-off cross-linking
administration of riboflavin for epi-on cross-linking
Sponsored by
University of Molise
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring cross-linking

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with evolving keratoconus
  • aged between 18 and 40 years
  • no evidence of corneal scarring

Exclusion Criteria:

  • patients with central and paracentral corneal opacities
  • Vogt's striae
  • previous intraocular surgery
  • history of herpetic keratitis
  • history of severe dry eye
  • concomitant autoimmune diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Epi-on cross-linking

    Epi-off cross-linking

    Arm Description

    Intervention: Drug: Riboflavin 0.15 in 20% dextran solution

    intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid

    Outcomes

    Primary Outcome Measures

    Best-corrected visual acuity after treatment
    Scale name: Early treatment diabetic retinopathy study (ETDRS) charts. Scale range 0-1. highest value of the range (corresponding to 20/20): 0 lowest value of the range (corresponding to 20/200): 1

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2018
    Last Updated
    July 14, 2018
    Sponsor
    University of Molise
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03598634
    Brief Title
    Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
    Official Title
    Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    June 30, 2015 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Molise

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
    Detailed Description
    The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus. Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    cross-linking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Epi-on cross-linking
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Drug: Riboflavin 0.15 in 20% dextran solution
    Arm Title
    Epi-off cross-linking
    Arm Type
    Active Comparator
    Arm Description
    intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid
    Intervention Type
    Procedure
    Intervention Name(s)
    administration of riboflavin for epi-off cross-linking
    Intervention Description
    riboflavin 0.1% in 20% dextran solution
    Intervention Type
    Procedure
    Intervention Name(s)
    administration of riboflavin for epi-on cross-linking
    Intervention Description
    riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
    Primary Outcome Measure Information:
    Title
    Best-corrected visual acuity after treatment
    Description
    Scale name: Early treatment diabetic retinopathy study (ETDRS) charts. Scale range 0-1. highest value of the range (corresponding to 20/20): 0 lowest value of the range (corresponding to 20/200): 1
    Time Frame
    up to 48 months from the recruitment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with evolving keratoconus aged between 18 and 40 years no evidence of corneal scarring Exclusion Criteria: patients with central and paracentral corneal opacities Vogt's striae previous intraocular surgery history of herpetic keratitis history of severe dry eye concomitant autoimmune diseases.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be made available once the studies results will be published

    Learn more about this trial

    Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients

    We'll reach out to this number within 24 hrs