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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456961

Enrollment

126

Registered

2015-05-29

Start date

2010-01-31

Completion date

2014-12-31

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

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

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.

Interventions

PROCEDUREiontophoresis of riboflavin

PROCEDUREepithelium-off

PROCEDURECorneal 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.

DEVICEgalvanizator, Potok-1

Device for providing iontophoresis procedure

DRUGDextralink

Riboflavin 0,1% + Dextran T-500

DRUGRiboflavin 0,1%

DEVICEUFalink

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Kmax, D	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

Measure	Time frame	Description
Corneal thickness, μm, as measured by OCT tomography	2 years	Using optical coherence tomography to estimate the pachymetry changes
Visual acuity as assessed by Decimal system	2 years	Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026