EVALUATION OF REFRACTIVE OUTCOMES OF SMILE PRO FOR MYOPIA AND ASTIGMATISM

Thị Phương Nguyễn 1,, Anh Tuấn Trần1, Kim Thành Đoàn 1
1 Pham Ngoc Thach University

Main Article Content

Abstract

Purpose: To evaluate the safety, efficacy, accuracy, and stability of Small Incision Lenticule Extraction Pro (SMILE Pro) using the VisuMax 800 femtosecond laser for myopia and myopic astigmatism. Methods: A prospective descriptive study was conducted on 80 eyes of 40 patients undergoing SMILE Pro at Saigon Eye Hospital Ngo Gia Tu from December 2024 to September 2025. Outcomes including uncorrected (UDVA) and corrected distance visual acuity (CDVA), spherical equivalent (SEQ), cylinder, central corneal thickness (CCT), higher-order aberrations (HOAs), efficacy and safety indices were assessed preoperatively and at 1, 3 months postoperatively. Data were analyzed using SPSS 26 with paired t-test, Wilcoxon, and Friedman tests (p < 0.05). Results: Mean age was 27.80 ± 4.758 years, with 42.5% female. Preoperative SEQ averaged −5.12 ± 1.92 D and cylinder −1.06 ± 0.68 D. At 3 months, mean UDVA was 0.013 ± 0.023 logMAR, with 97.5% of eyes achieving UDVA ≥ 20/20 and 100% ≥ 20/25. Mean CDVA was 0.00 ± 0.00 logMAR, with no eyes losing ≥2 lines. Mean SEQ was 0.0063 ± 0.11 D, with 97.5% within ±0.5 D and 100% within ±1.00 D of target. CCT decreased by 9.4% (p < 0.001), HOAs by 11% (p < 0.001), and TBUT by 7.8% temporarily (p < 0.05) but stabilized 3 months. Efficacy and safety indices were 1.04 each. Minor complications occurred in 7.5% (1.25% intraoperative, 6.25% postoperative), with no severe events. Conclusions: SMILE Pro provides excellent early visual outcomes, high refractive precision, and favorable safety profile, representing a significant advancement in corneal refractive surgery.

Article Details

References

1. Sekundo W., Kunert K. S., Blum M. (2011), "Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study", Br J Ophthalmol, 95 (3), pp. 335-339.
2. Yoo T. K., Kim D., Kim J. S. et al. (2024), "Comparison of early visual outcomes after SMILE using VISUMAX 800 and VISUMAX 500 for myopia: a retrospective matched case-control study", Sci Rep, 14 (1), pp. 11989.
3. Hong Son Cung, Tran L. H. T., Tran T. N. (2025), "Three-Month Outcomes of SMILE Pro with the VISUMAX 800 for Myopic Astigmatism in a Large Population", Clin Ophthalmol, 19, pp. 417-425.
4. Sekundo W., Chang J. S. M., Ganesh S. et al. (2025), "Keratorefractive Lenticule Extraction for Myopia and Myopic Astigmatism With the VISUMAX 800: 6-Month Outcomes of a Prospective Multi-center Post-market Clinical Follow-up Study", J Refract Surg, 41 (3), pp. e264-e271.
5. Holden B. A., Fricke T. R., Wilson D. A. et al. (2016), "Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050", Ophthalmology, 123 (5), pp. 1036-1042.
6. Ganesh S., Brar S. (2022), "Clinical outcomes of small incision lenticule extraction with fast scanning speed: SMILE PRO", Clinical Ophthalmology, 16, pp. 3501-3510.
7. Reinstein D. Z., Archer T. J., Potter J. G. et al. (2023), "Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800", Journal of Refractive Surgery, 39 (5), pp. 294-301.
8. Shah R., Shah S. (2011), "Effect of scanning patterns on the results of femtosecond laser lenticule extraction refractive surgery", Journal of Cataract & Refractive Surgery, 37 (9), pp. 1636-1647.
9. Reinstein D. Z., Archer T. J., Randleman J. B. (2013), "Mathematical model to compare the relative tensile strength of the cornea after PRK, LASIK, and SMILE", Journal of Refractive Surgery, 29 (7), pp. 454-460.