Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
NCT ID: NCT02456961
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2010-01-31
2014-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard epithelium-off CXL
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)
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.
Dextralink
Riboflavin 0,1% + Dextran T-500
UFalink
device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
Transepithelial CXL via iontophoresis of riboflavin
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
iontophoresis of riboflavin
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.
galvanizator, Potok-1
Device for providing iontophoresis procedure
Riboflavin 0,1%
UFalink
device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
Interventions
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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.
galvanizator, Potok-1
Device for providing iontophoresis procedure
Dextralink
Riboflavin 0,1% + Dextran T-500
Riboflavin 0,1%
UFalink
device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
Eligibility Criteria
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Inclusion Criteria
* 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
* History of epithelial healing problems.
* History or presence of ocular infection (such as herpes keratitis)
* Pregnancy and/or breastfeeding.
18 Years
ALL
No
Sponsors
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Ufa Eye Research Institute
OTHER
Responsible Party
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Principal Investigators
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Mukharram Bikbov, Professor
Role: STUDY_CHAIR
Ufa Eye Research Institute
Other Identifiers
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TCXL-ionto
Identifier Type: -
Identifier Source: org_study_id