ESCRS - FPS07.06 - Small Incision Lenticule Extraction (Smile) For Spherocylindrical Hyperopia: Results Of A Prospective Multicenter 12-Months Study

Small Incision Lenticule Extraction (Smile) For Spherocylindrical Hyperopia: Results Of A Prospective Multicenter 12-Months Study

Published 2022 - 40th Congress of the ESCRS

Reference: FPS07.06 | Type: Free paper | DOI: 10.82333/3nzd-xm51

Authors: Walter Sekundo* 1 , Dan Reinstein 2 , Pavel Stodulka 3 , Sri Ganesh 4 , Beatrice Cochener 5 , Marcus Blum 6 , Yan Wang 7 , Xingtao Zhou 8

1Ophthalmology,Philipps University of Marburg,Marburg,Germany;SMILEEYES,Marburg,Germany, 2London Vision Clinic,London,United Kingdom, 3Gemini Eye Clinic,Zlin,Czech Republic, 4Ophthalmology,Nethradhama Superspeciality Eye Hospital,Bangalore Jayanagar,India, 5Ophthalmology,Hospital Morvan,Brest,France, 6Ophthalmology,Helios Hospital,Erfurt,Germany, 7Tianjin Eye Hospital,Tianjin,China, 8EYE & ENT Hospital,Fudan University,Shanghai,China

Purpose

The aim of the present prospective multicentre study was to investigate the safety and the effectiveness of Small Incision Lenticule Extraction (SMILE) using the femtosecond laser system VisuMax® (Carl Zeiss Meditec AG) in hyperopic patients with or without astigmatism.

Setting

Prospective, multicenter, international, non-randomized, non-controlled clinical trial

Methods

374 eyes of 199 patients were treated.  In total, 9 visits were required (pre-op, treatment, 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperatively).The maximum correction allowed for the treatment was: sphere up to +6.00 D, cylinder up to 5.00 D and maximum hyperopic meridian up to +7.00 D. The preoperative corrected distance visual acuity (CDVA) should be 20/25 or better.  The optical zone was 6.3 mm with a transition zone of 2.0 mm. The lenticule thickness was set at 25 µm in the centre and at 10 µm the edge.

Results

The preoperative spherical equivalent (SE) of the manifest refraction was +3.20 ±1.48 D (+0.25 to +6.50 D). At the final 12 months follow-up visit 81% of eyes treated were within ± 0.50 D and 93% of eyes within 1.00 D of intended correction. 1.2% of eyes lost two or more lines of CDVA at the 12 months follow-up visit. 83.0% were at least 20/20 corresponding to the safety index of 1.005 at 12 months. Of the 219 eyes with plano target, 68.8% had an UDVA of 20/20 or better and 88% were at least 20/25 uncorrected at 12 months. There were no significant changes in contrast sensitivity.

Conclusions

Treatment of spherocylindrical hyperopia by SMILE led to refractive results similar to published outcomes on hyperopic Femto-Lasik using last generation excimer lasers.