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

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• Keratoconus 307

Keywords

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

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 126 is above the median of 40 across 203 interventional studies indexed under Keratoconus.

Lead sponsor

Ufa Eye Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  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)

  Procedure: epithelium-off · Procedure: Corneal collagen crosslinking · Drug: Dextralink · Device: UFalink

• Experimental
  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

  Procedure: iontophoresis of riboflavin · Procedure: Corneal collagen crosslinking · Device: galvanizator, Potok-1 · Drug: Riboflavin 0,1% · Device: UFalink

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

Primary outcomes

1. 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

   Time frame: 2 years

Secondary outcomes

1. Corneal thickness, μm, as measured by OCT tomography

   Using optical coherence tomography to estimate the pachymetry changes

   Time frame: 2 years

2. 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).

   Time frame: 2 years