The REVIVE Study: Long Term Outcomes of a Novel Non-Diffractive Extended Vision IOL versus Monofocal Control IOL.

ABSTRACT

Purpose: To evaluate the long-term (>1 yr) outcomes a non-diffractive extended vision intraocular lens (AcrySof IQ Vivity) compared to monofocal control. Setting: This was a multicenter trial that took place in 4 separate private ophthalmology practices throughout the United States. Design: This was a prospective, non-interventional, controlled, multicenter trial. All subjects were enrolled from participants in the Food and Drug Administration (FDA) clinical trial that led to the approval of the AcrySof IQ Vivity. Methods: Binocular uncorrected distance visual acuity (UCDVA), distance corrected visual acuity (DCVA), uncorrected intermediate visual acuity (UIVA) at 66cm, distance corrected intermediate visual acuity (DCIVA) at 66cm, uncorrected near visual acuity (UNVA) at 40cm, and distance corrected near visual acuity (DCNVA) at 40cm were measured. The binocular defocus curve was measured. A 23-question survey on visual performance including questions on spectacle independence, satisfaction, dysphotopsias, and likelihood of recommending their lens to another person was used administered. Results: A total of 64 eyes of 32 subjects were enrolled. Seventeen subjects had bilateral implantation of the AcrySof IQ Vivity lens, and 15 subjects had bilateral implantation of the AcrySof IQ Monofocal (SN60WF). Mean follow up time was 1078 days for the study group compared to 1067 days for the control group (p = 0.92). There were no differences in UCVA or DCVA between the two groups. Compared to control, the AcrySof IQ Vivity group had better mean binocular UIVA (logMAR 0.29 vs 0.18; p = 0.09), DCIVA (logMAR 0.33 vs 0.11; p = 0.003), UNVA (logMAR 0.49 vs 0.30, p = 0.01), and DCNVA (logMAR 0.54 vs 0.29; p = 0.001). Conclusion: The AcrySof IQ Vivity is a novel, non-diffractive extended range of vision intraocular lens that provides long-term, enhanced visual acuity at intermediate and near ranges with high levels of patient satisfaction and minimal dysphotopsias.