Clinical outcomes of the new generation VISUMAX 800 platform in small incision lenticule extraction for Myopia in Chinese patients

This retrospective multicentre study assessed early refractive outcomes and safety of small incision lenticule extraction (SMILE) in Chinese myopic eyes and characterised astigmatic accuracy and higher-order aberration (HOA) changes. Adults who underwent SMILE using new generation VISUMAX 800 with CentraLign centration and OcuLign iris registration participated. The participants comprised 319 patients (605 eyes) (mean age 20.6 ± 4.1 years; mean preoperative spherical equivalent [SE], - 3.88 ± 1.50 dioptres [D]). At 6 months, the mean uncorrected distance visual acuity was - 0.10 ± 0.05 logarithm of the minimum angle of resolution and mean manifest refractive SE was + 0.25 ± 0.33 D; 83.0% and 100.0% of eyes were within ± 0.50 D and ± 1.00 D of target SE, respectively. Residual cylinder was ≤ 0.50 D in 97.5% and ≤ 1.00 D in 100.0%. The Alpins analysis suggested mild undercorrection (correction index, 0.94 ± 0.23; difference vector, 0.21 ± 0.18 D). HOA root mean square increased (0.42 ± 0.03 to 0.57 ± 0.10 μm; P < 0.01), whereas spherical aberration was unchanged (P = 0.55). Decentration-coma analyses showed no significant associations between signed or total decentration parameters and corresponding coma changes after false discovery rate adjustment. Complications were infrequent. SMILE with VISUMAX 800 showed favourable early visual recovery, high predictability, low residual astigmatism, and acceptable safety profile in a multicentre real-world cohort.