Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL

Chandra Bala, Francisco Poyales, Mercè Guarro, Ramón Ruiz Mesa, Ali Mearza, Devesh Kumar Varma, Srichand Jasti, Jessie Lemp-Hull, Chandra Bala, Francisco Poyales, Mercè Guarro, Ramón Ruiz Mesa, Ali Mearza, Devesh Kumar Varma, Srichand Jasti, Jessie Lemp-Hull

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03010254.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.

Figures

Figure 1.
Figure 1.
a: Surface profiles of the DFT015 and SN60WF IOLs, (b) 7× magnification of the central element of DFT015, and (c) mechanism of action of the DFT015 IOL.
Figure 2.
Figure 2.
The mean binocular defocus curves (logMAR) at month 6. Best-case analysis set; 95% CIs.
Figure 3.
Figure 3.
The mean binocular contrast sensitivity at month 6 (safety analysis set): (a) mean mesopic without glare; (b) mean mesopic with glare; and (c) mean photopic without glare.
Figure 4.
Figure 4.
Frequency (a), severity (b), and bothersomeness (c) of visual disturbances at month 6. Overall percentages may not equate to 100% because of rounding. *Only 79 SN60WF recipients responded to the question regarding the frequency of halos.

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Source: PubMed

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