Article
Considering multicountry clinical outcomes of a novel presbyopia-correcting IOL
Author(s):
Study investigators compared 2 novel lens designs using data obtained from 19 investigational sites in Australia, Canada, Spain, and the UK
Superior intermediate/near visual acuity was achievable with a nondiffractive presbyopia-correcting IOL over an aspheric monofocal IOL in the study.
Chandra Bala, PhD, MBBA, FRANZCO, from PersonalEyes, Sydney, Australia, and colleagues reported that a non-diffractive presbyopia-correcting intraocular lens (IOL), the DFT015 (AcrySof IQ Vivity Extended Vision IOL, Alcon), provided superior intermediate and near vision and had a similar visual disturbance profile compared with an aspheric monofocal IOL, the SN60WF (AcrySof IQ monofocal IOL, Alcon).
Bala and colleagues conducted a prospective, randomized study to compare the 2 designs using data obtained from 19 investigational sites in Australia, Canada, Spain, and the UK.
The primary outcome was the superiority of the DFT015 IOL over the SN60WF IOL in the mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) by month 3 after implantation. The secondary outcomes were the noninferiority of the DFT015 IOL to the SN60WF IOL in the mean monocular photopic-corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3, the investigators recounted. The also assessed the visual disturbances at the 6-month time point.
The patients, all with bilateral cataracts, were randomized to receive 1 of the study IOLs that was implanted into both eyes of each patient. The eye with the worse preoperative CDVA was implanted first. All patients were followed out to 6 months after IOL implantation.
Effectiveness outcomes
A total of 282 patients participated in the study. The DFT015 IOL was implanted into 159 patients and the SN60WF IOL into 123 patients.
The investigators reported, “All effectiveness objectives were achieved at month 3 in the first eyes. For monocular photopic results in the first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of −0.139 logarithm of the minimum angle of resolution [logMAR] in favor of DFT015, p < 0.001), 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. The DFT015 exhibited a similar visual disturbance profile to that of SN60WF.”
The authors commented, “The new, nondiffractive presbyopia-correcting IOL, DFT015, provides a continuous extended range of vision, resulting in superior intermediate and near vision and noninferior distance vision compared with an aspheric monofocal IOL, SN60WF.”
Bala and colleagues recommended the DFT015 for patients whose daily priorities include activities in the distance to functional near range and who have a need for monofocal quality of distance vision.
