ESCRS - PO1175 - Incidence Of Suction Loss And Speed Of Lenticule Creation With Small-Incision Lenticule Extraction Using The Visumax 800 In A Post-Market Clinical Follow Up Study

Incidence Of Suction Loss And Speed Of Lenticule Creation With Small-Incision Lenticule Extraction Using The Visumax 800 In A Post-Market Clinical Follow Up Study

Published 2024 - 42nd Congress of the ESCRS

Reference: PO1175 | Type: Free paper | DOI: 10.82333/xvsz-y218

Authors: Rainer Wiltfang* 1 , John S M Chang 2 , Sri Ganesh 3 , Jesper Hjortdal 4 , Walter Sekundo 5

1Augenklinik Airport,Smileeyes Group,Munich,Germany, 2Refractive surgery centre,HKSH Healthcare ,Queensway,Hong Kong, 3Eye Hospital,Nethradhama,Banglaore,India, 4University Aarhus,Aarhus,Denmark, 5Gießen and Marburg,University Hosptal,Marburg,Germany

Purpose

 

Purpose: To report the incidence of suction loss and average time of lenticule creation in a population undergoing SMILE using the VISUMAX 800 as part of a Post-Market Clinical Follow-up (PMCF) study.

 

 

Setting

 

 

Setting: Multi-center clinical study across Europe and Asia.

 

 

 

 

 

 

 

Methods

Methods: This was a prospective, non-randomized, multi-center, international, post-market clinical follow-up study. 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). To evaluate speed of lenticule creation, a subset of surgical videos from the VISUMAX 800 were analyzed using video editing software. The videos were analyzed using a 30 frames per second (fps) time scale to increase accuracy of the timing assessment.

 

Results

Results: During the study period, 473 eyes (237 subjects) were enrolled, treated, and analyzed.  A subset of 20 subjects (40 eyes) across all sites were randomly chosen to retrospectively evaluate time taken for lenticule creation. One eye (1/473, 0.21%) experienced a suction loss, which was due to a resolved technical issue, not ocular movement. The treatment was restarted and completed successfully. The average time for lenticule creation, depending on laser and treatment settings used at the individual sites, was 9.98±1.86sec (7.27 to 13.29sec).

 

Conclusions

Conclusion: There were no cases of patient generated suction loss in this study which was likely due to the speed of the lenticule creation with the VISUMAX 800 femtosecond laser.