Pachymetric Assessment After EpiSmart® Epithelium-on Cross-Linking for Keratoconus and Post-Surgical Ectasia

The aim of this study was to assess changes in visual acuity after epithelium-on ("epi-on") corneal crosslinking after a diagnosis of keratoconus.Methods: Subjects with corneal ectatic diseases were enrolled in a prospective, randomized, controlled, open-label, multicenter trial. Subjects were randomized to 1 of 3 treatment groups and treated with an epi-on crosslinking system including riboflavin/sodium iodide and pulsed UVA exposure (EpiSmart, CXL Ophthalmics, Encinitas, CA). The UVA treatment groups were 2.4 J/cm 2 over 20 minutes, 3.6 J/cm 2 over 20 minutes, and 3.6 J/cm 2 over 30 minutes. The primary end point was logarithm of the minimum angle of resolution corrected distance visual acuity (CDVA). Secondary end points were logarithm of the minimum angle of resolution uncorrected distance visual acuity (UCVA), maximum corneal curvature (Kmax), and minimum corneal thickness. Data were assessed 6 and 12 months post-operatively, using t-tests for differences from baseline.Results: Two thousand two hundred twenty-eight subjects were treated with epi-on crosslinking. One thousand nine hundred twentytwo subjects had a diagnosis of keratoconus; other treated eyes had postsurgical and other ectasias. At 6 and 12 months, the subjects with keratoconus demonstrated significant improvements in CDVA, UCVA, and Kmax; minimum corneal thickness was unchanged. One hundred ninety-five subjects (8.7%) reported at least 1 adverse event (AE). A mild corneal epithelial defect was reported in 31 cases (1.4%) and was the only AE reported in .1% of subjects. There were no serious AEs related to the treatment.Conclusions: EpiSmart epi-on crosslinking resulted in mean improvements in CDVA, UCVA, and Kmax at both 6 and 12 months and an excellent safety and efficacy profile in subjects with keratoconus, with few significant side effects. Differences between UVA treatment groups were not significant.

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“…This confirms a pilot study which also observed no change in minimal thickness with the EpiSmart technique. 32 …”

Section: Discussionmentioning

confidence: 99%

EpiSmart Crosslinking for Keratoconus: A Phase 2 Study

Epstein

Belin

Gravemann

et al. 2022

Cornea

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“…This might be accomplished by enhancing epithelial penetration and reducing riboflavin photodegradation (Rubinfeld et al, 2021). Recently, they have conducted phase 2 trials of EpiSmart ® epi-on in 1606 KCN patients, and substantiated the excellent safety and efficacy profile of their system during 12-month observation (Epstein et al, 2022;Vaidya et al, 2022).…”

Section: Sodium Iodide (Nai)mentioning

confidence: 99%

Recent advances in medicinal compounds related to corneal crosslinking

Qin,

Han,

Wang

et al. 2023

Front. Pharmacol.

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Corneal crosslinking (CXL) is the recognized technique to strengthen corneal collagen fibers through photodynamic reaction, aiming to halt progressive and irregular changes in corneal shape. CXL has greatly changed the treatment for keratoconus (KCN) since it was introduced in the late 1990’s. Numerous improvements of CXL have been made during its developing course of more than 20 years. CXL involves quite a lot of materials, including crosslinking agents, enhancers, and supplements. A general summary of existing common crosslinking agents, enhancers, and supplements helps give a more comprehensive picture of CXL. Either innovative use of existing materials or research and development of new materials will further improve the safety, effectiveness, stability, and general applicability of CXL, and finally benefit the patients.

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Pachymetric Assessment After EpiSmart® Epithelium-on Cross-Linking for Keratoconus and Post-Surgical Ectasia

Cited by 2 publications

References 21 publications

EpiSmart Crosslinking for Keratoconus: A Phase 2 Study

EpiSmart Crosslinking for Keratoconus: A Phase 2 Study

Recent advances in medicinal compounds related to corneal crosslinking

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