Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design.

PURPOSE: To evaluate the effectiveness and safety of the DFT015 intraocular lens (IOL) (AcrySof IQ Vivity Extended Vision) compared with an aspheric monofocal control IOL (AcrySof IQ model SN60WF). SETTING: 11 investigation sites in the U.S. DESIGN: Prospective randomized controlled clinical study. METHODS: Patients aged 22 years or older with bilateral cataracts were randomized to receive bilateral implantation of DFT015 or SN60WF. The 4 coprimary effectiveness outcomes (6 months postoperatively) were monocular photopic distance-corrected intermediate visual acuity (DCIVA), monocular photopic corrected distance visual acuity (CDVA), monocular depth of focus (DoF), and the percentage of patients achieving a DCIVA of 0.2 logMAR or better. The mean monocular photopic distance-corrected near visual acuity (DCNVA) was a secondary effectiveness outcome. Safety and patient-reported visual disturbances were evaluated through questionnaires. RESULTS: 218 patients (435 eyes) completed the study. Compared with SN60WF, DFT015 demonstrated superior mean monocular photopic DCIVA ( P < .001), noninferior mean monocular photopic CDVA, and superior mean monocular photopic DCNVA ( P < .001) and provided an extended monocular DoF (increase of 0.54 diopters at 0.2 logMAR). With DFT015, 78 first eyes (72.9%) achieved a DCIVA of 0.2 logMAR or better at 6 months. Incidences of ocular serious adverse events and patient-reported most bothersome visual disturbances were low and consistent between groups. CONCLUSIONS: DFT015 is safe and effective for the visual correction of aphakia, exceeding American National Standards Institute criteria for an extended depth-of-focus IOL by providing superior DCIVA and DCNVA, with comparable CDVA and visual disturbances to the SN60WF monofocal IOL.

Defocus curves: focusing on factors influencing assessment.

Defocus curve assessment is used to emulate defocus over a range of distances and is a valuable tool that is used to differentiate the performance of presbyopia-correcting intraocular lenses. However, defocus curves are limited by a lack of standardization, and multiple factors can affect their generation and interpretation. This review discusses key factors that influence the assessment of defocus curves, including pupil size, level of contrast, sphere vs cylinder defocus, viewing distance, monocular vs binocular assessment, use of Snellen vs logMAR charts, and diopter range and step size. Moreover, different methods to analyze defocus curves, including the direct comparison method, range-of-focus analysis, and area under the curve analysis, can affect result interpretation. A good understanding of these factors and standardization of the methodology are important to ensure optimal cross-study comparisons.

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.

PURPOSE: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. SETTING: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. DESIGN: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. METHODS: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. RESULTS: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF. CONCLUSIONS: DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.