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

NCT02456961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Keratoconus

Interventions

PROCEDURE

iontophoresis of riboflavin

PROCEDURE

epithelium-off

PROCEDURE

Corneal collagen crosslinking

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.

DEVICE

galvanizator, Potok-1

Device for providing iontophoresis procedure

DRUG

Dextralink

Riboflavin 0,1% + Dextran T-500

DRUG

Riboflavin 0,1%

DEVICE

UFalink

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

Sponsors & Collaborators

  • Ufa Eye Research Institute

    lead OTHER

Principal Investigators

  • Mukharram Bikbov, Professor · Ufa Eye Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456961 on ClinicalTrials.gov