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

NCT02456961 | Completed DMC

• 1 other identifier: TCXL-ionto
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Keratoconus

Keywords

Collagen crosslinking (CXL); Standard corneal crosslinking (CXL); Transepithelial CXL; Iontophoresis; Riboflavin

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (2)

• Corneal thickness, μm, as measured by OCT tomography

  2 years

• Visual acuity as assessed by Decimal system

  2 years

Study Arms (2)

Standard epithelium-off CXL

ACTIVE COMPARATOR

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)

Procedure: epithelium-off; Procedure: Corneal collagen crosslinking; Drug: Dextralink; Device: UFalink

Transepithelial CXL via iontophoresis of riboflavin

EXPERIMENTAL

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

Procedure: iontophoresis of riboflavin; Procedure: Corneal collagen crosslinking; Device: galvanizator, Potok-1; Drug: Riboflavin 0,1%; Device: UFalink

Interventions

iontophoresis of riboflavin PROCEDURE

Transepithelial CXL via iontophoresis of riboflavin

epithelium-off PROCEDURE

Standard epithelium-off CXL

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.

Standard epithelium-off CXL; Transepithelial CXL via iontophoresis of riboflavin

galvanizator, Potok-1 DEVICE

Device for providing iontophoresis procedure

Transepithelial CXL via iontophoresis of riboflavin

Dextralink DRUG

Riboflavin 0,1% + Dextran T-500

Standard epithelium-off CXL

Riboflavin 0,1% DRUG

Transepithelial CXL via iontophoresis of riboflavin

UFalink DEVICE

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

Standard epithelium-off CXL; Transepithelial CXL via iontophoresis of riboflavin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ufa Eye Research Institute: lead

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Mukharram Bikbov, Professor

  Ufa Eye Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 29, 2015

Record last verified: 2015-05