ESCRS - PO0617 - Study Of Clinical And Morphological Changes In Patients Affected By Keratoconus Submitted To Epi Off Accelerated Corneal Cross Linking Using An Hypoosmolar Charged Riboflavin Solution. 18 Months Of Follow Up

Study Of Clinical And Morphological Changes In Patients Affected By Keratoconus Submitted To Epi Off Accelerated Corneal Cross Linking Using An Hypoosmolar Charged Riboflavin Solution. 18 Months Of Follow Up

Published 2023 - 41st Congress of the ESCRS

Reference: PO0617 | Type: Free paper | DOI: 10.82333/rv6n-z492

Authors: Paolo Garimoldi* 1 , Massimo De Molfetta 1 , Paolo Radice 2

1Ophthalmolgy Department,Ospedale Galmarini Tradate,Tradate,Italy, 2Ophthalmolgy Department,Ospedale di Circolo Fondazione Macchi,Varese,Italy

Purpose

Recrolin + (SOOFT Italia S.p.A.) is an  hypoosmolar charged riboflavin solution dextran-free that uses EDTA 0,1% and trometamol 0,05% as enhancers to optimize riboflavin stromal penetration by iontophoresis. Its ability to reach higher concentrations in the corneal stroma compared to standard riboflavin has been demonstrated both with the epi off technique and with iontophoresis. This riboflavin has been specifically designed for the treatment of cross linking with iontophoresis. However, this specific riboflavin solution is commonly used in epi off cross linking procedure.

This study evaluates the efficacy and safety of the use of Recrolin+ riboflavin in epi off accelerated cross linking treatment of progressive keratoconus.

Setting

Ospedale Galmarini, Ophthalmolgy Dept., Tradate, ASST-SetteLaghi

Ospedale di Circolo Fondazione Macchi, Ophthalmolgy Dept., Varese, ASST-SetteLaghi

Methods

52 eyes of 48 patients (29 male, 19 female. Mean age 22 years), affected by progressive keratoconus, undergoing accelerated epi off cross linking (10mW/cm2, 9min) using ETDA and trometamol-enriched riboflavin hypotonic solution (Recrolin+). Corrected distance visual acuity (CDVA), slit lamp examination, tomograph examination (Sirius, CSO) and coherent optical tomography (OCT) (Optovue, Alfa Intes) were assessed before cross linking and 45 days, 3, 6, 12 and 18 months after.  Parameters examined included Corneal Steepest Point (Kmax), thinnest corneal thickness (ThCT), Anterior symmetry index (Sif), Baiocchi Calossi Versaci back index (BCVb), Demarcation Line Depht (DLD). Thinnest corneal thickness was assesed with OCT and tomograph.

Results

CDVA improved in 41 eyes, remained stable in 10 eyes, got worse in 1. Mean CDVA ( LogMAR 0,17 at baseline) worsened at day 45 (LogMAR 0,21) and progressively improved up to month 18 (LogMAR 0,07). Mean KMax increased of 1.1 diopter at day 45 and decreased in the following examination up to month 18. Tomographic indexes Sif and BCVb worsened at day 45, then improved, showing a progressive regularization of both cornea surfaces.  
Mean ThCT reduced at day 45 (-73μm tomograph, -40μm OCT ), then gradually increased without ever reaching the initial values. Mean DLD measured with OCT was at 332μm from the epithelium. A mild corneal haze was detected at day 45 in 40% of cases and it disappeared in all cases between month 3 and month 6.

Conclusions

Epi off accelerated cross linking treatment using a hypoosmolar charged riboflavin solution is an effective and safe teqnique in halting the progression of keratoconus.
Morphological changes consisting of significative flattening of the maximal anterior curvature and regularization of the corneal surfaces were observed in all cases and were accompanied by an improvement in corrected visual acuity in most cases.
 A process of progressive flattening of the corneal surface, although reducing over time, continued throughout the observation period in majority of cases. 
A longer observation period would be needed to understand the duration of this process.