Visual Performance of a non-diffractive Extended Depth of Focus IOL in Early-Stage Keratoconus: Prospective Pilot Study
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Aims : To evaluate visual performance, contrast sensitivity (CS), optical quality, and subjective satisfaction of Vivity extended depth-of-focus (EDOF) intraocular lens (IOL) in early keratoconus (KC). Methods : In this prospective, interventional, single-centre clinical study, ten patients with mild bilateral KC and cataract received AcrySof IQ Vivity IOL. 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 (Snellen 20/25) ± 0.15 and 0.14 (20/30) ± 0.16 logMAR, respectively. The defocus curve was ≤ 0.20 logMAR (Snellen 20/32) 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). Mean RMS and Strehl ratio were higher at 3 mm. Higher patient-reported outcomes were in glare, clarity, and correction satisfaction. Conclusion : The AcrySof IQ Vivity IOL showed excellent visual and functional outcomes in early-stage KC, with strong CS and minimal dysphotopsia, supporting this non-diffractive EDOF IOL as a premium option in carefully selected mild KC cases.