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Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iontophoresis of riboflavin
epithelium-off
Corneal collagen crosslinking
galvanizator, Potok-1
Dextralink
Riboflavin 0,1%
UFalink
Sponsored by
Ufa Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Collagen crosslinking (CXL), Standard corneal crosslinking (CXL), Transepithelial CXL, Iontophoresis, Riboflavin

Eligibility Criteria

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

Inclusion Criteria:

  • Documented progressive KC (by Pentacam and/or corneal topography imaging).
  • A clear central cornea.
  • A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
  • Minimal Snellen corrected distance visual acuity of ≥ 0.4.
  • Patient age of ≥ 18 years.

Exclusion Criteria:

  • Corneal scarring.
  • History of epithelial healing problems.
  • History or presence of ocular infection (such as herpes keratitis)
  • Pregnancy and/or breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard epithelium-off CXL

    Transepithelial CXL via iontophoresis of riboflavin

    Arm Description

    Removing the central 8-10mm of the epithelium and applying a riboflavin solution (0.1% riboflavin-5-phosphate and 20% dextran T-500) to the corneal surface 30 minutes before irradiation and at 5 minutes intervals during the course of a 30 minute exposure to 370 nm UVA with an irradiance of 3 mWcm-2 (UFalink, Russian Federation)

    impregnation of the cornea with a riboflavin 0.1% hypotonic solution is performed by using an iontophoresis device (galvanizator; Potok-1, Russian Federation). The passive electrode (anode) was applied to the inferior part of the cervical vertebrae. The active electrode (cathode), a bath tube (glass or plastic - 10-12 ml) is applied to the open eye,then r the tube is taped to the skin of the orbital margins and filled with riboflavin 0.1%. The current intensity is initially 0.2 mA and then gradually increased to 1.0 mA at 0.2 mA for 1 minute at 10-second intervals increments to determine individual tolerance. The total time that the riboflavin administration is 10 minutes. Standard surface UVA irradiation (370 nm, 3 mW/cm2) using UFalink device, (Russian Federation) is then applied at a 5-cm distance for 30 minutes with continuing hypotonic riboflavin drops every 2 minutes

    Outcomes

    Primary Outcome Measures

    Kmax, D
    Using topography measurements, clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value

    Secondary Outcome Measures

    Corneal thickness, μm, as measured by OCT tomography
    Using optical coherence tomography to estimate the pachymetry changes
    Visual acuity as assessed by Decimal system
    Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).

    Full Information

    First Posted
    May 20, 2015
    Last Updated
    May 26, 2015
    Sponsor
    Ufa Eye Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02456961
    Brief Title
    Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
    Official Title
    Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ufa Eye Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation. In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Collagen crosslinking (CXL), Standard corneal crosslinking (CXL), Transepithelial CXL, Iontophoresis, Riboflavin

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Standard epithelium-off CXL
    Arm Type
    Active Comparator
    Arm Description
    Removing the central 8-10mm of the epithelium and applying a riboflavin solution (0.1% riboflavin-5-phosphate and 20% dextran T-500) to the corneal surface 30 minutes before irradiation and at 5 minutes intervals during the course of a 30 minute exposure to 370 nm UVA with an irradiance of 3 mWcm-2 (UFalink, Russian Federation)
    Arm Title
    Transepithelial CXL via iontophoresis of riboflavin
    Arm Type
    Experimental
    Arm Description
    impregnation of the cornea with a riboflavin 0.1% hypotonic solution is performed by using an iontophoresis device (galvanizator; Potok-1, Russian Federation). The passive electrode (anode) was applied to the inferior part of the cervical vertebrae. The active electrode (cathode), a bath tube (glass or plastic - 10-12 ml) is applied to the open eye,then r the tube is taped to the skin of the orbital margins and filled with riboflavin 0.1%. The current intensity is initially 0.2 mA and then gradually increased to 1.0 mA at 0.2 mA for 1 minute at 10-second intervals increments to determine individual tolerance. The total time that the riboflavin administration is 10 minutes. Standard surface UVA irradiation (370 nm, 3 mW/cm2) using UFalink device, (Russian Federation) is then applied at a 5-cm distance for 30 minutes with continuing hypotonic riboflavin drops every 2 minutes
    Intervention Type
    Procedure
    Intervention Name(s)
    iontophoresis of riboflavin
    Intervention Type
    Procedure
    Intervention Name(s)
    epithelium-off
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal collagen crosslinking
    Intervention Description
    Standard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    galvanizator, Potok-1
    Intervention Description
    Device for providing iontophoresis procedure
    Intervention Type
    Drug
    Intervention Name(s)
    Dextralink
    Intervention Description
    Riboflavin 0,1% + Dextran T-500
    Intervention Type
    Drug
    Intervention Name(s)
    Riboflavin 0,1%
    Intervention Type
    Device
    Intervention Name(s)
    UFalink
    Intervention Description
    device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
    Primary Outcome Measure Information:
    Title
    Kmax, D
    Description
    Using topography measurements, clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Corneal thickness, μm, as measured by OCT tomography
    Description
    Using optical coherence tomography to estimate the pachymetry changes
    Time Frame
    2 years
    Title
    Visual acuity as assessed by Decimal system
    Description
    Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented progressive KC (by Pentacam and/or corneal topography imaging). A clear central cornea. A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging). Minimal Snellen corrected distance visual acuity of ≥ 0.4. Patient age of ≥ 18 years. Exclusion Criteria: Corneal scarring. History of epithelial healing problems. History or presence of ocular infection (such as herpes keratitis) Pregnancy and/or breastfeeding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mukharram Bikbov, Professor
    Organizational Affiliation
    Ufa Eye Research Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin

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