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Completed

NCT Number: NCT02456961

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iontophoresis of riboflavin

Procedure

epithelium-off

Procedure

Corneal collagen crosslinking

Procedure

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.

galvanizator, Potok-1

Device

Device for providing iontophoresis procedure

Dextralink

Drug

Riboflavin 0,1% + Dextran T-500

Riboflavin 0,1%

Drug

Ufalink

Device

device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2

Primary outcomes

  1. Kmax, D

    Time frame: 2 years

    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 outcomes

  1. Corneal thickness, μm, as measured by OCT tomography

    Time frame: 2 years

    Using optical coherence tomography to estimate the pachymetry changes

  2. Visual acuity as assessed by Decimal system

    Time frame: 2 years

    Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).

Sponsors and collaborators

Lead sponsor

Ufa Eye Research Institute

Other

Registry information

Official study title

Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 29, 2015
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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