Clinical Data

Halt the Progression of Keratoconus

With Pulsed, Accelerated Corneal Cross-linking Using iLink® V

Prospective clinical study conducted in the UK demonstrates the power of iLink® V with VibeX Rapid and the KXL to slow or halt the progression of keratoconus.1

Pre- and post-operative progression defined using the limits of keratometric repeatability established by the Global Delphi Panel of Keratoconus and Ectatic Diseases.2

Defining disease progression in early keratoconus and moderate to advanced keratoconus

Group 1 (Kmax < 55D) (1 or more)

  • ≥ 1 D increase Kmax
  • ≥ 1 D increase front K1 or K2
  • ≥ 0.5 D increase back K2
  • ≥ 16 μm decrease minimum corneal thickness
Group 2 (Kmax ≥ 55D) (1 or more)

  • ≥ 2.5 D increase Kmax
  • ≥ 2.5 D increase front K1 or K2
  • ≥ 22 μm decrease minimum corneal thickness

Criteria for determining progression in early and moderate/advanced keratoconus, based on differences in measurement repeatability limits in early and advanced keratoconus. Kmax, maximum keratometry; K1, flat keratometry in the central 3 mm zone; K2, steep keratometry in central 3 mm zone

98.3% of progressive keratoconus patients treated with iLink® V achieved stability at 24 months.

No significant reduction in corrected distance visual acuity (CDVA), endothelial cell density (ECD), no clinical endothelial cell decompensation observed in this independent clinical study.

Bar graph showing 98.3% of progressive keratoconus patients treated with iLink V achieved stability at 24 months.

98.3% of progressive keratoconus patients treated with iLink® V achieved stability at 24 months.

No significant reduction in corrected distance visual acuity (CDVA), endothelial cell density (ECD), no clinical endothelial cell decompensation observed in this independent clinical study.

Short Procedure Duration with Long Term Benefits

Five-Year Outcomes of Accelerated Corneal Cross-linking using iLink® V

Independent retrospective study of accelerated cross-linking with iLink® V in patients with mild to moderate keratoconus (Amsler-Krumeich Grade I to III) demonstrated stability or improvement in Kmax between 24 months and 5 years.3

Anterior Kmax at 3 mm decreased significantly by 24 months (P = .009), remaining reduced relative to baseline at 60 months (P = .017), n=29.

Anterior Kmax at 6 mm decreased significantly by 24 months (P = .035), remaining reduced relative to baseline at 60 months (P = .027) n=29.

No postoperative complications such as corneal infections, infiltrates, or irreversible corneal opacities were observed at any time point during this study.

Bar graph of Five-Year Outcomes of Accelerated Cross-linking using iLink V showing stability or improvement in Kmax between 24 months and 5 years.

Citation:

  1. Gore, Daniel M., et al. American Journal of Ophthalmology 2021 Jan;221:9-16
  2. Gomes JA, Tan D, Rapuano CJ, Belin MW, Ambrósio R Jr, Guell JL, Malecaze F, Nishida K, Sangwan VS; Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases. Global consensus on keratoconus and ectatic diseases. Cornea. 2015
  3. Moramarco A, et al. J Refract Surg. 2020 Nov 1;36(11):724-730.

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Intended Use

The KXL® System is intended for illuminating the cornea during corneal cross-linking procedures stabilizing cornea which have been weakened by disease or by refractive surgery.

Safety Information

The KXL® System is contraindicated where the corneal thickness, with epithelium, is less than < 375 microns, in corneal melting disorders, aphakic patients, pseudophakic patients without UV blocking lens implanted, pregnant and nursing women, and children. Possible risks may include corneal haze, delayed epithelial healing, corneal edema, stromal scarring, keratitis by infection and sterile infiltrates. For full information consult the directions for use.