Factors Affecting Visual Outcome After Small Lenticule Extraction Pro® (VISUMAX 800).

Abstract

Purpose: This study aimed to report factors affected visual outcome after small incision lenticule extraction (SMILE) in the early experience of treating eyes with VISUMAX 800 (Carl Zeiss Meditec AG).

Methods: This is a retrospective study with cross-sectional design of eyes underwent SMILE Pro® using VISUMAX 800 in JEC @Kedoya Eye Hospital Jakarta, Indonesia. Patients 40 years old or younger with the corrected distance visual acuity (CDVA) of >20/25, manifest refractive spherical equivalent (SE) ≤10.0 diopters (D), cylinder refraction <5.0 D were included. Evaluation of visual outcome was conducted at 1 day and 1 month postoperatively. All statistical analyses were performed using the SPSS v. 26.0 software (IBM Corp.) based on data normality.

Results: A total of 258 eyes from 132 patients were analyzed. 94% of eyes achieve uncorrected distance visual acuity (UDVA) 20/20 1-month post operatively. 81% of high myopic eye achieve UDVA 20/20 following by 97% and 99% in moderate and low myopic eyes, respectively. Spherical equivalent refraction (SER) (r = 0.273; p < 0.01), optic zone (OZ) (r = 0.260; p < 0.01), cap thickness (r = 0.209; p < 0.01), and residual stromal thickness (RST) (r = 0.256; p < 0.01) showed a statistically significant but weak correlation with UDVA 1 month postoperatively. There is increasing risk to get <20/20 UDVA in right eyes (OR 3.101; p<0.045), eyes with high myopia (OR 9.964; p<0.01), 100µm cap thickness (OR 4.578; p<0.01), ≤ 6mm OZ (OR 10.556; p<0.01), and <300µm RST (OR 9.100; p<0.01) 1-month post operatively.

Conclusions: SMILE Pro® give promising visual outcome in early post operative period. Low-moderate myopia give better visual outcome than high myopia patient. Small OZ, thin cap thickness, and low RST could increase risk for not getting a maximum visual outcome after SMILE. Study with prospective design and longer follow up time which included comprehensive variables were needed to fully understand factors affecting VA after SMILE.