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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456961
• Other study ID #: TCXL-ionto
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: May 26, 2015
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Ufa Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• iontophoresis of riboflavin

• epithelium-off

• 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
• Riboflavin 0,1%

Device:
• UFalink
device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ufa Eye Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Corneal thickness, µm, as measured by OCT tomography	Using optical coherence tomography to estimate the pachymetry changes	2 years
Secondary	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).	2 years