Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
Not Applicable
Completed
- Conditions
- Keratoconus
- Interventions
- Procedure: iontophoresis of riboflavinProcedure: epithelium-offProcedure: Corneal collagen crosslinkingDevice: galvanizator, Potok-1Drug: DextralinkDevice: UFalink
- Registration Number
- NCT02456961
- Lead Sponsor
- Ufa Eye Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transepithelial CXL via iontophoresis of riboflavin galvanizator, Potok-1 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 Standard epithelium-off CXL Dextralink 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) Standard epithelium-off CXL Corneal collagen crosslinking 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) Transepithelial CXL via iontophoresis of riboflavin 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 Transepithelial CXL via iontophoresis of riboflavin Riboflavin 0,1% 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 Standard epithelium-off CXL epithelium-off 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) Transepithelial CXL via iontophoresis of riboflavin Corneal collagen crosslinking 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 Standard epithelium-off CXL UFalink 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) Transepithelial CXL via iontophoresis of riboflavin UFalink 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Corneal thickness, μm, as measured by OCT tomography 2 years Using optical coherence tomography to estimate the pachymetry changes