Visual And Refractive Outcomes From A Multicentric, Prospective Study In Patients Bilaterally Implanted With An Enhanced Monofocal Intraocular Lens

To evaluate the performance of the enVista Aspire (toric/non-toric) intraocular lenses (IOLs) with respect to visual and refractive outcomes following bilateral implantation in patients undergoing cataract surgery.

57 sites in the United States

In this prospective, multicenter, open-label, single-arm post-marketing clinical study, cataract patients aged ≥ 22 years with corrected distance visual acuity (CDVA) equal to or worse than 20/40 and an estimated CDVA better than 20/30 after IOL implantation in each eye were enrolled. All patients underwent bilateral implantation with the enVista Aspire toric or non-toric IOLs, targeting plano to first minus. Study parameters included binocular uncorrected and corrected visual acuities at far and intermediate distances (UDVA, UIVA, CDVA, DCIVA).

A total of 313 subjects underwent bilateral implantation with the study IOLs. Three subjects discontinued after IOL implantation; thus, 310 subjects were analyzed. At postoperative 14 to 42 days after IOL implantation in the second eye, the mean MRSE was -0.18 ± 0.37 D. The mean binocular UDVA and UIVA were 0.02 ± 0.10 and 0.20 ± 0.15, respectively. While 90.6% of eyes achieved binocular UDVA of 20/25 or better, 70.9% of eyes achieved UIVA of 20/32 or better. Mean binocular CDVA and DCIVA were -0.03 ± 0.07 and 0.23 ± 0.16, respectively. Binocular DCIVA of 20/32 or better were achieved in 64.4% of eyes, respectively.

Cataract patients bilaterally implanted with the enhanced monofocal IOL demonstrated good distance and intermediate visual acuities, with functional near visual acuity. These results are attributed to the optical modification of the posterior aspheric surface of the IOL, which creates a small, continuous increase in power within the central 1.5 mm diameter, thereby slightly extending the depth of focus. This enhanced monofocal IOL can be considered an ideal option for patients seeking good intermediate vision without compromising distance vision.