Abstract
Purpose :
To compare binocular distance, intermediate, and near visual acuity and patient reported outcomes of non-diffractive extended depth of focus (ND-EDOF; Alcon Vivity) and neutral aspheric monofocal (Bausch & Lomb enVista) intraocular lenses.
Methods :
This was a prospective, single-center, patient and assessor-masked clinical study. Qualified subjects were randomized to receive either the ND-EDOF or monofocal IOL in both eyes, targeted for emmetropia. Post-operatively, subjects underwent examination at regularly scheduled intervals through 3 months. The primary endpoint was the mean logMAR best-distance corrected visual acuity at intermediate (DCIVA; 66 cm) tested in binocular photopic conditions. Secondary endpoints included binocular best-corrected distance (BCDVA; 4 m) and best-distance corrected near (DCNVA; 40 cm) visual acuity. Subjects’ outcomes will also be assessed by way of questionnaires evaluating visual disturbances and spectacle dependence.
Results :
Fifty-six subjects have been enrolled to date. Thirty (ND-EDOF = 15; monofocal = 15) and 20 (ND-EDOF = 9; monofocal = 11) subjects have completed the one- and three month study visits, respectively. At one month, the binocular BCDVA, DCIVA and DCNVA’s were -0.003 ± 0.09, -0.019 ± 0.12, and 0.03 ±0.13 for the ND-EDOF lens and -0.016 ± 0.05 (p = 0.83), 0.17 ± 0.12 (p = 0.0009), and 0.17 ± 0.14 (p = 0.0126) logMAR for the monofocal IOL, respectively. This equates to two lines of improvement compared to the monofocal lens results. Clinically speaking, the ND-EDOF IOL resulted in 93% of patients obtaining 20/25 or better at intermediate and 87% obtaining 20/25 or better at near. This compares with 40% at intermediate and 47% at near for the same thresholds in patients implanted bilaterally with the monofocal.
Conclusions :
The ND-EDOF had similar distance vision and provided two lines of improvement for both intermediate and near vision when compared to the monofocal IOL with a neutral aspheric optical profile.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.