[Clinical outcomes of a monocular bi-aspheric ablation profile for the correction of refractive errors associated with presbyopia].

Abstract

Objective: To explore the safety, efficacy, predictability, binocular visual balance, and postoperative visual quality of a monocular bi-aspheric ablation profile combined with laser corneal refractive surgery in patients with refractive errors associated with presbyopia, and to provide clinical evidence for individualized surgical correction of presbyopia. Methods: This retrospective case series study included 64 patients (128 eyes) with refractive errors and presbyopia treated at Gansu Aier Eye Hospital from April 2022 to April 2026, comprising 25 males and 39 females with a mean age of (46.66±4.87) years. The dominant eye was designated for distance vision and treated with small-incision lenticule extraction (SMILE) or femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) according to the corneal characteristics and refractive status; the non-dominant eye was designated for near vision and treated with a monocular bi-aspheric ablation profile combined with FS-LASIK, in which a certain degree of residual myopia and negative spherical aberration were intentionally induced to increase depth of focus and enhance near vision. Postoperative follow-ups were conducted at 1 day, 1 month, 3 months, and 6 months. Binocular uncorrected distance visual acuity(BUDVA), binocular uncorrected near visual acuity (BUNVA), refractive outcomes, higher-order aberrations, and subjective visual quality were evaluated. Results: Subgroup analysis based on dominant-eye surgical procedure showed no significant differences in postoperative binocular distance or near visual acuity between the SMILE and LASIK groups. Pooled analysis showed that BUDVA remained stable throughout follow-up and was comparable to the preoperative level, while BUNVA was significantly improved postoperatively. At 1 month postoperatively, 94.2%(49/52) of patients achieved binocular uncorrected distance visual acuity of 20/25 or better, and 80.7%(42/52) achieved 20/20 or better; meanwhile, 94.2%(49/52) achieved BUNVA of 0.8 or better, and 80.7% (42/52)achieved 1.0 or better. The median efficacy index was 1.11 (interquartile range, 1.0 to 1.2). Postoperatively, uncorrected distance visual acuity was significantly better in the dominant eye than in the non-dominant eye (P<0.001), whereas uncorrected near visual acuity was significantly better in the non-dominant eye than in the dominant eye (P=0.010), indicating successful establishment of the intended monocular bi-aspheric visual profile. At 6 months, actual spherical equivalent correlated strongly with the predicted values in both dominant and non-dominant eyes (R²=0.924 and 0.922, respectively; all P<0.001). Safety analysis showed that 90.7%(39/43) of patients had postoperative distance visual acuity that remained stable or improved, with only 9.3%(4/43) experiencing a decline; for near visual acuity, 51.2% improved by 2 or more lines and only 2.3% declined. At 6 months, the root mean square of higher-order aberrations in non-dominant eyes increased significantly compared with baseline (P=0.027), whereas spherical aberration showed a decreasing trend without statistical significance. On the subjective visual quality questionnaire, most patients reported no or only occasional visual disturbances. Conclusions: The monocular bi-aspheric ablation profile combined with laser corneal refractive surgery demonstrated favorable safety, efficacy, and predictability in patients with refractive errors and presbyopia. It effectively enhanced near visual acuity while maintaining distance vision, thereby achieving binocular visual balance with good postoperative visual quality, and supporting its role as an individualized surgical approach for presbyopia correction.