PURPOSE: To evaluate the real-world clinical performance of the enhanced monofocal enVista Aspire and Aspire Toric intraocular lenses (IOLs) and to assess surgeon and subject satisfaction in subjects undergoing bilateral cataract surgery. The enhanced monofocal IOL is a one-piece hydrophobic acrylic IOL with a posterior squared step edge and modified C-Loop design; the enVista Aspire IOL uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly broaden the depth of focus from distance to intermediate.

SETTING: 57 sites in the United States.

METHODS: This was a prospective, multicenter, open-label, single-arm, post-market clinical study. Subjects scheduled for bilateral implantation in cataract surgery were enrolled and screened for eligibility through a chart review (Preoperative Visit 0). To be eligible, subjects needed to be 22 years of age or older, with a CDVA equal to or worse than 20/40 in each eye, clear intraocular media other than the cataract in both eyes and stable refraction in contact lens users. Exclusion criteria included any corneal pathology, anterior segment pathology (eg, pseudoexfoliation syndrome, synechiae, iris atrophy), glaucoma, retinal detachment or retinal pathology, congenital ocular anomaly, and previous intraocular or corneal surgery. Postoperatively, all eyes underwent ophthalmic examinations at regular intervals through Postoperative Visit 1 (14 to 42 days after second eye IOL implantation). Performance endpoints included monocular and binocular uncorrected and corrected visual acuity at distance (UDVA, CDVA), intermediate (UIVA, DCIVA) and near (UNVA, DCNVA), patient-reported outcomes (AIOLIS, NAVQ and VISIBL) and ocular adverse events.

RESULTS: A total of 313 subjects underwent bilateral implantation with the study IOLs; three subjects were discontinued after IOL implantation, thus 310 subjects were analyzed. The study was conducted by 57 Principal Investigators (84 implanting surgeons). Mean binocular CDVA was -0.03 ± 0.07 logMAR, with 97.7% of patients achieving 20/25 or better. 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 DCIVA was 0.23 ± 0.16, with binocular DCIVA of 20/32 or better achieved in 64.4% of eyes. The AIOLIS demonstrated that 89.6% of subjects were satisfied with their vision; overall, 92.5% of subjects reported that their vision was good to excellent, 92.6% were seeing pretty well or better without corrective devices, and 86.7% rated their intermediate vision as good or better without corrective devices. Analysis of NAVQ responses showed that 70-72% of patients could perform intermediate vision tasks without spectacles, such as viewing a computer or mobile device display, with 'no or a little difficulty', and 72% of patients were satisfied with their near vision. Most ocular adverse events were considered related only to the study procedure, and not the study device.

CONCLUSIONS: This open-label post-marketing study demonstrated excellent safety and efficacy for the enVista Aspire and enVista Aspire Toric IOLs. Patients achieved good distance visual acuity with functional intermediate visual acuity, showing a broadened depth of focus, and a high percentage of patients were satisfied with their vision.