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

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ClinicalTrials.gov Identifier: NCT03598634
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ciro Costagliola, University of Molise

Study Description
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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.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: administration of riboflavin for epi-off cross-linking Procedure: administration of riboflavin for epi-on cross-linking Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Epi-on cross-linking
Intervention: Drug: Riboflavin 0.15 in 20% dextran solution
 Procedure: administration of riboflavin for epi-off cross-linking
riboflavin 0.1% in 20% dextran solution

Procedure: administration of riboflavin for epi-on cross-linking
riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
Active Comparator: Epi-off cross-linking
intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid
 Procedure: administration of riboflavin for epi-off cross-linking
riboflavin 0.1% in 20% dextran solution

Procedure: administration of riboflavin for epi-on cross-linking
riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid


Outcome Measures
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Primary Outcome Measures :
  1. Best-corrected visual acuity after treatment [ Time Frame: up to 48 months from the recruitment ]
    • 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ciro Costagliola, Full Professor in Ophthalmology, University of Molise
ClinicalTrials.gov Identifier: NCT03598634    
Other Study ID Numbers: 0001-05-2018
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be made available once the studies results will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ciro Costagliola, University of Molise:
cross-linking
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents