Multi-country clinical outcomes of a new nondiffractive presbyopia-correcting intraocular lens.

Purpose To evaluate the effectiveness and safety of a novel presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. Setting Nineteen investigational sites in four 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 best-corrected distance visual acuity (BCDVA), and superiority in mean monocular photopic distance-corrected near visual acuity (DCNVA) at Month 3. Visual disturbances were assessed at Month 6. Results Two-hundred-and-eighty-two 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 (LS Means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean BCDVA (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 provides superior intermediate and near vision, and a similar visual disturbance profile, compared with an aspheric monofocal IOL.