SMILE for Hyperopia With and Without Astigmatism: Results of a Prospective Multicenter 12-Month Study.

PURPOSE: To investigate the safety and effectiveness of small incision lenticule extraction (SMILE) in patients who have hyperopia with or without astigmatism.

METHODS

This was a prospective multicenter trial including 374 eyes of 199 patients treated by SMILE for hyperopia using the VisuMax femtosecond laser (Carl Zeiss Meditec AG). Inclusion criteria were sphere up to +6.00 diopters (D), cylinder up to 5.00 D, and maximum hyperopic meridian up to +7.00 D, with preoperative corrected distance visual acuity (CDVA) of 20/25 or better. The optical zone was 6.3 mm with a transition zone of 2 mm. The minimum lenticule thickness was set at 25 µm in the center and at 10 µm at the edge. Patients were examined at 1 day, 1 week, and 1, 3, 6, 9, and 12 months after surgery. Standard refractive surgery outcomes analysis was performed.

RESULTS

The preoperative spherical equivalent was +3.20 ± 1.48 D (range: +0.25 to +6.50 D). At the 12-month follow-up visit, 81% of eyes treated were within ±0.50 D and 93% of eyes were within ±1.00 D of intended correction. A total of 1.2% of eyes lost two or more lines of CDVA at the 12-month follow-up visit, and 83% were at least 20/20, corresponding to a safety index of 1.005 at 12 months. Of the 219 eyes with plano target, 68.8% had an uncorrected distance visual acuity of 20/20 or better and 88% were at least 20/25 uncorrected at 12 months. There were no statistically significant changes in contrast sensitivity.

CONCLUSIONS

SMILE was found to be an effective treatment method for the correction of compound hyperopic astigmatism, demonstrating a high level of efficacy, predictability, safety, and stability. [J Refract Surg. 2022;38(12):760-769.].