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.

Patient and Economic Burden of Presbyopia: A Systematic Literature Review.

PURPOSE: The objective of this systematic literature review (SLR) was to collate, report, and critique published evidence related to epidemiology and patient and economic burden of presbyopia. PATIENTS AND METHODS: A systematic literature search was conducted in MEDLINE®, Embase®, and Cochrane Library databases from the time of inception through October 2018 using Cochrane methodology. Studies published in English language reporting on epidemiology and patient and economic burden of presbyopia were included. RESULTS: Initial systematic literature search yielded 2,228 citations, of which 55 met the inclusion criteria (epidemiology, 44; patient burden, 14; economic burden, 1) and were included in this review. Globally, 1.09 billion people are estimated to be affected by presbyopia. The reported presbyopia prevalence varied across regions and by age groups, with the highest prevalence of 90% reported in the Latin America region in adults ≥35 years. Presbyopic patients report up to 22% decrease in quality-of-life (QoL) score, and up to 80% patients with uncorrected presbyopia report difficulty in performing near-vision related tasks. About 12% of presbyopes required help in performing routine activities, and these visual limitations reportedly induce distress and low self-esteem in presbyopia patients. Uncorrected presbyopia led to a 2-fold increased difficulty in near-vision-related tasks and a >8-fold increased difficulty in very demanding near-vision-related tasks. Further, uncorrected presbyopia leads to a decrement in patients' QoL, evident by the low utility values reported in the literature. Annual global productivity losses due to uncorrected and under-corrected presbyopia in working-age population (<50 years) were estimated at US$ 11 billion (0.016% of the global domestic product (GDP) in 2011, which increased to US$ 25.4 billion if all people aged <65 years were assumed to be productive. CONCLUSION: Uncorrected presbyopia affects patients' vision-related quality of life due to difficulty in performing near-vision-related tasks. In addition, un-/under-corrected presbyopia could lead to productivity losses in working-age adults.

Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial.

SIGNIFICANCE: Lotrafilcon B lenses packaged in and cared for with block copolymer-containing (polyoxyethylene-polyoxybutylene; EOBO) lens care solutions resulted in lower cholesterol extraction than each of the habitual silicone hydrogel lens/multipurpose solution (MPS) regimens tested. PURPOSE: This study aimed to compare the extracted cholesterol of lotrafilcon B lenses packaged in and cared for with EOBO-containing lens care solutions with the extracted cholesterol of habitual silicone hydrogel lenses cared for with MPS not containing EOBO. METHODS: In this prospective, randomized, observer-masked parallel study, habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS were randomized 1:1 to lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS. Subjects randomized to lotrafilcon B were further randomized to one of two EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde (Alcon Laboratories, Inc., Fort Worth, TX). A subset of right eye lenses was collected after wear, and total cholesterol was extracted and measured using a fluorometric enzymatic assay. RESULTS: Of 143 lenses analyzed, 95 were from subjects randomized to their habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE PUREMOIST. The mean amounts of cholesterol extracted from lotrafilcon B + EOBO lenses cared for with CLEAR CARE PLUS with HydraGlyde (0.28 ± 0.18 µg/lens) and OPTI-FREE PUREMOIST (0.28 ± 0.48 µg/lens) were significantly lower than those extracted from senofilcon C (4.18 ± 3.25 µg/lens), senofilcon A (2.19 ± 2.69 µg/lens), comfilcon A (2.17 ± 1.47 µg/lens), and samfilcon A (2.07 ± 1.48 µg/lens) lenses used with MPS (P < .0001 each). CONCLUSIONS: Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.