Mesopic Contrast Sensitivity Evaluation After Small-Incision Lenticule Extraction Using The Visumax 800 In A Post-Market Clinical Follow Up Study

Published 2024 - 42nd Congress of the ESCRS

Reference: FP20.07 | Type: Free paper | DOI: 10.82333/c5d7-nm94

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

¹Aarhus University Hospital,Aarhus,Denmark, ²Queensway,HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre,Hong Kong,Hong Kong, ³Nethradhama Superspeciality Eye Hospital,Bangalore,India, ⁴University Hospital Gießen and Marburg,Marburg,Germany, ⁵Smile Eyes,München,Germany

Purpose

To report the mesopic monocular contrast sensitivity change in a population undergoing SMILE using the VISUMAX 800 in a Post-Market Clinical Follow-up (PMCF) study.

Setting

Multi-center clinical study across Europe and Asia.

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). Patients were examined at 1-day, 1-week, 1-month, 3-months, and 6-months after treatment. Monocular mesopic contrast sensitivity was measured preoperative and 6-month postoperative at 3,6,12, and 18 cycles per degree(cpd) using the CSV-1000E (VectorVision) under a luminance of 3 cd/m².

Results

During the study period, 473 eyes (237 subjects) were enrolled, treated, and analyzed. Preoperatively the contrast sensitivity (log units) based on matched pairs (n=446) was 1.642±0.219, 1.614±0.300, 1.086±0.380, and 0.613±0.369 at 3,6,12 and 18cpd respectively. At the 6-month postoperative visit the contrast sensitivity was 1.678±0.205, 1.629±0.295, 1.092±0.416, and 0.662±0.339 at 3,6,12, and 18cpd.

Conclusions

While likely not clinically significant, there a slight increase in contrast sensitivity results across all tested cycles per for subjects that underwent SMILE with the VISUMAX 800 for myopia or myopic astigmatism.