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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iontophoresis of riboflavin | Procedure |
| ||
| epithelium-off |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal thickness, μm, as measured by OCT tomography | Using optical coherence tomography to estimate the pachymetry changes | 2 years |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mukharram Bikbov, Professor | Ufa Eye Research Institute | Study Chair |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 23, 2016 | |
| Reset | Jan 19, 2017 |
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| Procedure |
|
| 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. |
|
| galvanizator, Potok-1 | Device | Device for providing iontophoresis procedure |
|
| Dextralink | Drug | Riboflavin 0,1% + Dextran T-500 |
|
| Riboflavin 0,1% | Drug |
|
| UFalink | Device | device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2 |
|
| 2 years |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2016 | Jan 19, 2017 |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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