Visual performance of a non-diffractive extended depth of focus IOL in stable early-stage Keratoconus: prospective pilot study.

AIMS: To evaluate visual performance, contrast sensitivity (CS), optical quality, and subjective satisfaction of Vivity extended depth-of-focus (EDOF) premium intraocular lens (pIOL) in early keratoconus (KC).

METHODS

In this prospective, interventional, single-center clinical study, ten patients with mild bilateral KC and cataract received AcrySof IQ Vivity pIOL. Pre- and postoperative assessments included monocular and binocular uncorrected and distance-corrected visual acuities at 4 m (UDVA, DCVA), uncorrected and distance-corrected intermediate and near visual acuities at 66 cm (UI66VA, DCI66VA) and 40 cm (UNVA, DCNVA), defocus curve, CS, wavefront aberrometry (RMS, PSF, Strehl ratio), halometry, and subjective outcomes.

RESULTS

At 3 months, mean ± SD monocular DCVA in the dominant eyes (primary endpoint) was 0.06 ± 0.13 logMAR. A statistically significant improvement was observed between preoperative and postoperative monocular and binocular UDVA, UNVA, DCNVA (p < 0.001), and DCVA (p = 0.03). Binocular DCI66VA and UI66VA were 0.10 ± 0.15 and 0.14 ± 0.16 logMAR, respectively. The defocus curve was ≤ 0.20 logMAR from + 0.50 D to - 2.00 D. CS peaked under scotopic conditions at 6 cpd, total ocular RMS improved from 2.15 ± 1.98 to 1.09 ± 0.77 (p = 0.09). NEI-RQL-42 scores indicated favourable patient-reported outcomes, particularly for glare, clarity of vision, and satisfaction with correction.

CONCLUSION

In this small prospective pilot study, bilateral implantation of a non-diffractive EDOF IOL was associated with favourable short-term visual outcomes in highly selected patients with stable early keratoconus. These preliminary findings suggest that early stable KC may not represent an absolute contraindication to non-diffractive EDOF IOL implantation, but larger comparative studies with longer follow-up are required.