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

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.

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.

Evaluation of Quality of Vision and Visual Outcomes with Bilateral Implantation of a Non-Diffractive Extended Vision Intraocular Lens with a Target of Slight Myopia in the Non-Dominant Eye.

PURPOSE: To assess the visual outcomes and quality of vision of patients receiving the AcrySof® IQ Vivity™ non-diffractive extended vision intraocular lens (NDEV IOL) after uneventful cataract surgery when the non-dominant eye is targeted for slight myopia. DESIGN: Single site, prospective, single-arm study. METHODS: Eligible subjects interested in reducing their dependence on spectacles over a range of working distances were enrolled and followed for 3 months after the second eye surgery. Subjects were bilaterally implanted with this NDEV IOL, with a target of emmetropia in the dominant eye and a myopic refraction of -0.75D in the non-dominant eye. At 3 months postoperative, the uncorrected and distance-corrected (with monovision) visual acuity at 40 cm, 66 cm and 4 m were recorded, along with the manifest refraction. Questionnaires related to spectacle independence, patient satisfaction and quality of vision were also administered. RESULTS: Data from 33 subjects were analyzed. The mean difference between eyes by subject was 0.80 ± 0.37 D. Twenty-nine of 33 (88%) subjects had a binocular uncorrected near VA of 0.2 logMAR or better. Twenty-five of 33 eyes (76%) had a binocular distance-corrected (-0.75 D in the non-dominant eye) VA of 0.2 logMAR or better at all three test distances. Satisfaction with vision at all distances was high. The reported level of spectacle independence was higher than for the same lens without monovision. Visual disturbances were higher than has been previously reported for this lens but were not correlated to the level of monovision. CONCLUSION: A target of -0.75 D of myopia in the non-dominant eye of patients bilaterally implanted with this NDEV IOL improved near vision, increasing the rate of spectacle independence in patients relative to those targeted for bilateral emmetropia, with no correlated increases in visual disturbances.

Prospective multicenter trial assessing effectiveness, refractive predictability and safety of a new aberration free, bi-aspheric intraocular lens.

PURPOSE: To determine the effectiveness and safety of the Softec HD IOL; and to present refractive outcomes for lenses manufactured at an IOL power tolerance of 0.11 D. METHODS: Three-hundred and ninety adult patients requiring removal of a cataractous lens with implantation of a monofocal IOL in at least one eye were eligible for study participation across eight US investigative sites. Patients were enrolled unilaterally. After routine surgery, subjects were examined for adverse events (AEs), best corrected visual acuity (BCVA) and manifest refraction correction at 12 months postoperatively. RESULTS: Three-hundred and sixty-six (95%) of patients completed the 12-month postoperative visit. The percent of patients achieving best corrected Snellen acuity 20/40 or better was 98.9%, and 81.1% of patients achieved best corrected Snellen acuity 20/25 or better. Of those patients (80%) implanted with a lens available in 0.25 D increments (manufactured at a tolerance of 0.11 D) 40.9%, 69.8% and 93.8% of patients were within ±0.25 D, ±0.50 D and ±1.0 D of predicted target refraction respectively. Overall incidence of cumulative and persistent IOL Grid AEs was 2.2% with no AE meeting or exceeding the FDA Grid of Historical Controls. CONCLUSIONS: The Softec HD IOL is a safe and effective lens. The high manufacturing tolerance of the lens appears to enhance refractive outcomes.

Parachute-like harness to position patients with severe kyphosis during cataract surgery.

We describe a technique to position patients with severe kyphosis so the head is horizontal. The legs are lifted into the Trendelenburg position, and the patient is supported with straps similar to those of a parachute. Although the patient's legs are high above the head and jugular distension has been observed, we have not noticed posterior pressure in the 2 cases we describe. This technique is similar to that described by others but has the additional security of the parachute-like straps.

Bilateral Artisan lens for aphakia and megalocornea: Long-term follow-up.

We received approval from the U.S. implant Food and Drug Administration and the University's Institutional Review Board to the Artisan lens (Ophtec BV) in both eyes of a patient who was aphakic and had megalocornea. No other intraocular lens would easily solve this patient's need because of the large anterior segment. The patient was having increasing difficulty with aphakic contact lenses because of his work environment. We present almost 5 years of follow-up data of this patient.