ESCRS - PO1151 - 12-Month Visual And Refractive Outcomes After Small-Incision Lenticule Extraction Using The Visumax 800 Femtosecond Laser

12-Month Visual And Refractive Outcomes After Small-Incision Lenticule Extraction Using The Visumax 800 Femtosecond Laser

Published 2024 - 42nd Congress of the ESCRS

Reference: PO1151 | Type: Free paper | DOI: 10.82333/ht46-nh13

Authors: Anke Messerschmidt-Roth* 1 , Walter Sekundo 2

1eye hospital ,Philipps-University Marburg,Marburg,Germany, 2eye Hospital,Philipps-University Marburg,Marburg,Germany

Purpose

To report the three-month and one-year outcomes of patients undergoing SMILE Pro with the VISUMAX 800.

Setting

University Hospital Gießen and Marburg, Marburg, Germany

Methods

The 3-month data was collected as part of a prospective, non-randomized, multi-center, international, post-market clinical follow-up study for the VM800. The study took place from June 23, 2021 to July 20, 2023. Subjects meeting all inclusion criteria including myopia up to 10 D and astigmatism up to 5 D were enrolled to undergo SMILE using the VISUMAX 800 femtosecond laser (Carl Zeiss Meditec). Patients were examined at 1‑day, 1‑week, 1-month, 3-months, and 6-months after treatment. Subjects enrolled in the study were invited to continue standard of care for the site and return for a 12-month postoperative visit.

Results

During the study period, 90 eyes were treated. At the time of analysis, all eyes were available at 3 months and 62% were available at 12 months. The preop SEQ was ‑4.48±2.27 (-1.37 to -10.00D). Preop CDVA was 20/20 or better in 97% of eyes. At 3 months, UDVA was 20/20 or better in 91% and 20/25 or better in 99% of eyes. Accuracy of SEQ to intended showed 88% of eyes within ±0.50D and 100% within ±1.00D. The mean SEQ refraction was 0.03D. At 12 months, UDVA was 20/20 or better in 93% and 20/25 or better in 98% of eyes. Accuracy of SEQ to intended showed 94% of eyes within ±0.50D and 100% of eyes within ±1.00D. The mean SEQ refraction was 0.06D. No eyes lost 2 or more lines of CDVA compared to baseline at either timepoint.

Conclusions

SMILE Pro with the VISUMAX 800 provides excellent visual and refractive outcomes for patients with myopia and myopic astigmatism and shows stability between 3 months and 12 months postoperative.