Outcomes Of Smile Combined With Custom Fast Corneal Cross-Linking (X-Combi-Cf) Versus Smile Alone In Myopic Patients: A 12-Month Retrospective Study
Published 2025 - 43rd Congress of the ESCRS
Reference: PP12.16 | Type: Free paper | DOI: 10.82333/sva2-zq37
Authors: Ferdinando Cione* 1 , Maddalena De Bernardo 2 , Ilenia Di Paola 2 , Domenico Mucci 2 , Isabella Pellegrino 2 , Immacolata Ruggiero 2 , Mario Graziano 3 , Nicola Rosa 2
1Eye Unit, Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana”,University of Salerno,Salerno,Italy;University Eye Clinic,AOU San Giovanni di Dio e Ruggi D'Aragona ,Salerno,Italy, 2Eye Unit, Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana”,University of Salerno,Salerno,Italy, 3Eye Unit, Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana”,University of Salerno,Salerno,Italy;Eye Unit,AORN San Giuseppe Moscati,Avellino,Italy
Purpose
The aim of this study is to compare the clinical outcomes of small incision lenticule extraction (SMILE) alone versus SMILE combined with Custom Fast corneal cross-linking (X-COMBI-CF) in myopic patients over a 12-month period.
Setting
This single-center retrospective interventional comparative study included patients treated at San Rossore Pisa Eye Clinic, Italy, by the same surgeon (M.F.). It was approved by the local Institutional Ethics Committee (Comitato Etico Regione Toscana-Area Vasta Centro, n. 120/2023) and followed the principles of the Declaration of Helsinki.
Methods
23 myopic patients were involved. 10 underwent bilateral SMILE, and 13 X-COMBI-CF with 2 protocols: OD (epi-on soaking with Ribocross® TE, 15 mW/cm² for 2 min) and OS (intrastromal imbibition with Ribofast®, 30 mW/cm² for 90 sec). Outcomes assessed at 1 day, 1 week, and 1, 3, 6, and 12 months included spherical equivalent (SE), uncorrected visual acuity (UCVA), best-corrected visual acuity (BSCVA), keratometry (K1, K2), pachymetry (TPP), endothelial cell density (ECD), pupil diameter, higher-order aberrations (HOABs), spherical aberration (SA), and COMA. Exclusion criteria: hyperopia, TPP<450um, keratoconus, glaucoma, corneal scarring, retinal disease, eye infection, previous herpetic infection, severe DED, pregnancy/breastfeeding, age<18.
Results
No significant differences were observed between groups for SE, UCVA, BSCVA, keratometry, TPP, ECD, or pupil diameter (p > 0.05). However, X-COMBI-CF significantly reduced HOABs (1M p = 0.003; 3M p < 0.0003; 6M p < 0.0001; 12M p < 0.0001), SA (1M p = 0.0143; 3M p = 0.0003; 6M p = 0.0017; 12M p = 0.0111), and COMA (1M p = 0.0205; 3M p = 0.0200; 6M p = 0.0003; 12M p = 0.0010). Both X-COMBI-CF protocols produced comparable results, with no corneal haze reported.
Conclusions
X-COMBI-CF provides significant improvements in higher-order aberrations, spherical aberrations, and COMA compared to SMILE alone. Both X-COMBI-CF protocols showed comparable results without corneal haze, suggesting benefits beyond ectasia prevention. Particularly beneficial for patients with borderline corneas or those at risk of postoperative ectasia, X-COMBI-CF also has potential as a standard treatment for enhancing optical quality in all SMILE patients. Unlike traditional cross-linking protocols focused on corneal strengthening, X-COMBI-CF combines biomechanical reinforcement with improvements in optical performance. Further long-term follow-up is needed to assess corneal stability and the potential for routine use.