Purpose: To report the outcomes of small incision lenticule extraction (SMILE) using the VISUMAX 800 laser (Carl Zeiss Meditec) in a post-market clinical follow-up study.
Methods: This was a prospective, non-randomized, multi-center, international, post-market clinical follow-up study. The study took place from July 2021 to March 2023 at five sites across Europe and Asia. Patients meeting all inclusion criteria including myopia up to -10.00 diopters (D) and astigmatism up to 5.00 D were enrolled to undergo SMILE using the VISUMAX 800 femtosecond laser (Carl Zeiss Meditec). Patients were examined at 1 day, 1 week, and 1, 3, and 6 months after treatment.
Results: During the study period, 473 eyes (237 patients) were enrolled, treated, and analyzed. The preoperative spherical equivalent was -4.49 ± 1.87 D (range -0.25 to -10.00 D). Preoperative corrected distance visual acuity (CDVA) was 20/20 or better in 98.3% of eyes. At 6 months postoperatively, uncorrected distance visual acuity was 20/20 or better in 93.2% and 20/25 or better in 98.3% of eyes. Accuracy of spherical equivalent to intended target showed 95.1% of eyes were within ±0.50 D and 99.6% were within ±1.00 D for spherical equivalent and 90.8% of eyes were within ±0.50 D and 99.7% were within ±1.00 D for cylinder. There was a slight increase in monocular mesopic contrast sensitivity across all cycles per degree. There was one reported case of suction loss, which was not due to ocular movement. No eyes lost two or more lines of CDVA compared to baseline.
Conclusions: SMILE with the VISUMAX 800 provides excellent visual and refractive outcomes for patients with myopia and myopic astigmatism. .
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| http://dx.doi.org/10.3928/1081597X-20250204-03 | DOI Listing |
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Purpose: To report the outcomes of small incision lenticule extraction (SMILE) using the VISUMAX 800 laser (Carl Zeiss Meditec) in a post-market clinical follow-up study.
Methods: This was a prospective, non-randomized, multi-center, international, post-market clinical follow-up study. The study took place from July 2021 to March 2023 at five sites across Europe and Asia.
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Methods: This was a retrospective clinical study of subjects that underwent keratorefractive lenticule extraction (KLEx) with the VISUMAX 800 at Hong Son Eye Hospital (Ha Noi, Vietnam) between June 2023 and October 2023. Primary outcome measures of monocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and refraction, including vector analysis, were evaluated at 3-months postoperatively.
Comparison Between Topographic-Based and Manifest-Based Astigmatism Corrections in the Second (Visumax 800)-Generation Keratorefractive Lenticule Extraction Surgery: A Real-World Study.
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: To evaluate the effectiveness of astigmatism correction between topographic- and manifest-based methods in individuals who underwent second-generation keratorefractive lenticule extraction (KLEx) surgery. : This study was conducted with participants who underwent second-generation KLEx surgery. After exclusion, there were 46 and 43 participants in the manifest and topographic groups, respectively.
View Article and Find Full Text PDFPurpose: To compare the clinical outcomes, surgical workflow, and patient satisfaction following small incision lenticule extraction (SMILE) performed with the VisuMax 800 in one eye and the VisuMax 500 in the contralateral eye (both Carl Zeiss Meditec).
Methods: This was a prospective, single-site clinical study of patients undergoing SMILE for myopia and myopic astigmatism between February 2022 and August 2023. Each patient underwent bilateral treatment using the VisuMax 800 (VM800 group) in one eye and the VisuMax 500 (VM500 group) in the contralateral eye.
Purpose: To evaluate the visual outcomes of keratorefractive lenticule extraction using a new version of a femtosecond laser platform with semi-automated cyclotorsion compensation in comparison to the previous generation without cyclotorsion control.
Methods: This was an ambispective study of consecutive eyes treated by SMILE with the VisuMax and VISUMAX 800 femtosecond lasers at the Uma Eye clinic, Chennai, India between June 2022 and July 2023. Inclusion criteria were myopia up to -10 D and astigmatism between 1.
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