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Corneal cross-linking in Keratoconus

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Last updated: July 18th, 2022

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Summary of Evidence

Corneal collagen cross-linking

Corneal collagen crosslinking was effective in improving the maximum keratometry value and visual acuity in eyes with progressive keratoconus at 1 year after treatment, with an excellent safety profile. (Hersh et.al, 2017). {Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270.}

Evidence

1. Background

Clinical Trial

2021 Larkin et.al. (KERALINK)

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2021
Clinical Trial

Keratoconus progression in the study eye occurred 7% of patients randomized to CXL compared with 43% randomized to standard care. Patients in the CXL arm had on average 90% lower odds of experiencing progression compared with those receiving standard care. {Larkin DFP, Chowdhury K, Burr JM, Raynor M, Edwards M, Tuft SJ, Bunce C, Caverly E, Doré C; KERALINK Trial Study Group. Effect of Corneal Cross-linking versus Standard Care on Keratoconus Progression in Young Patients: The KERALINK Randomized Controlled Trial. Ophthalmology. 2021 Nov;128(11):1516-1526.}

Larkin et.al. (KERALINK)
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2. Protocols

2.1 Standard protocol

Clinical Trial

2017 Hersh et.al.

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2017
Clinical Trial

Corneal collagen crosslinking was effective in improving the maximum keratometry value and visual acuity in eyes with progressive keratoconus at 1 year after treatment, with an excellent safety profile. {Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270.}

  • Clinical trial of patients aged ≥ 14yo with progressive keratoconus randomized to either standard CXL or control (205 patients)
  • Findings (1-year):
    • Max K decreased by 1.6 dioptres in the treatment group vs continued progression in control group.
    • CDVA improved by 5.7 logMAR units, while UCVA improved 4.4 logMAR units.
    • Corneal haze was the most frequent adverse event
    • There was no significant change in endothelial cell count

Hersh et.al.
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Case series

2003 Wollensak et.al.

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2003
Case series

Progression was stopped in all eyes treated with corneal collagen crosslinking. There was regression in maximal keratometry readings in 70% of eyes. {Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7.}

  • Clinical trial of patients with keratoconus treated with standard CXL (22 patients)
  • Findings (2-years):
    • Progression of keratoconus was stopped in all eyes.
    • There was regression in 70% of eyes.
    • Visual acuity improved slightly in 65% of eyes.
    • Corneal and lens transparency, endothelial cell density and intraocular pressure was unchanged.

Wollensak et.al.
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2.2 Accelerated protocol

Case series

2021 Gore et.al.

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2021
Case series

At 2 years, there was keratometric stabilisation in 98.3% of eyes, with no change in corrected distance visual acuity, manifest refraction and endothelial cell density. {Gore DM, Leucci MT, Koay SY, Kopsachilis N, Nicolae MN, Malandrakis MI, Anand V, Allan BD. Accelerated Pulsed High-Fluence Corneal Cross-Linking for Progressive Keratoconus. Am J Ophthalmol. 2021 Jan;221:9-16.}

  • Clinical trial of patients aged ≥ 16yo with progressive keratoconus treated with accelerated pulsed high-fluence corneal crosslinking (870 patients)
  • Findings (2-years):
    • In mild cones group (Kmax < 55 dioptres), mean keratometry was unchanged at 2 years
    • In advanced cones group (Kmax ≥ 55 D), there was modest corneal flattening but no significant change in central keratometry when compared to baseline.
    • There was keratometric stabilisation in 98.3% of eyes
    • There was no change in mean CDVA, manifest refraction and endothelial cell density

Gore et.al.
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Prospective study

2021 Kandel et.al.

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2021
Prospective study

This real-world observational study found that both standard and accelerated CXL were similarly safe and effective in stabilizing keratoconus at 1-year postsurgery. The findings support the adoption of accelerated CXL for time and convenience.{Kandel H, Nguyen V, Ferdi AC, Gupta A, Abbondanza M, Sullivan L, Apel A, Watson SL. Comparative Efficacy and Safety of Standard Versus Accelerated Corneal Crosslinking for Keratoconus: 1-Year Outcomes From the Save Sight Keratoconus Registry Study. Cornea. 2021 Dec 1;40(12):1581-1589.}

Kandel et.al.
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2.3 Transepithelial protocol

Case series

2018 Hersh et.al.

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2018
Case series

Transepithelial corneal crosslinking resulted in significant improvement in maximum keratometry and uncorrected visual acuity at 1 year. {Hersh PS, Lai MJ, Gelles JD, Lesniak SP. Transepithelial corneal crosslinking for keratoconus. J Cataract Refract Surg. 2018 Mar;44(3):313-322.}

  • Clinical trial of patients aged ≥ 14yo with keratoconus treated with transepithelial corneal crosslinking (56 patients)
  • Findings (1-year):
    • At 1 year, maximum K decreased significantly by 0.45 diopters (D)
    • Mean UDVA significantly improved by 0.7 lines
    • CDVA improved by 0.2 lines.

Hersh et.al.
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Case series

2013 Caporossi et.al.

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2013
Case series

Functional results showed instability of keratoconus at 2 years, with functional regression in patients aged 19-26years old. {Caporossi A, Mazzotta C, Paradiso AL, Baiocchi S, Marigliani D, Caporossi T. Transepithelial corneal collagen crosslinking for progressive keratoconus: 24-month clinical results. J Cataract Refract Surg. 2013 Aug;39(8):1157-63.}

  • Clinical trial of patients aged ≤ 26yo with progressive keratoconus treated with transepithelial corneal crosslinking (26 patients)
  • Findings (2-years):
    • Uncorrected and corrected distance acuity returned to baseline preoperative values at 2 years.
    • Maximum keratometry worsened at 2 years after 1 year of stability.
    • Pachymetry significantly decreased at 2 years.
    • 50% of paediatric patients were re-treated with epi-off CXL due to significant deterioration of all parameters

Caporossi et.al.
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References

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