Aims: To compare clinical outcomes of patients bilaterally implanted with SN60D3 intraocular lenses (IOLs) with outcomes of bilateral monofocal controls, and to determine the validity of implanting an apodised diffractive lens in a healthy patient population.
Methods: Six unmasked US investigators prospectively enrolled 72 patients aged ⩽70 years with bilateral cataracts in otherwise healthy eyes. Patients underwent routine cataract extraction via phacoemulsification with SN60D3 implantation. Visual outcomes were assessed 1 week, 1 month and 6 months postoperatively. Patients completed two subjective surveys. As controls, 51 patients who were 6 months postoperative to bilateral implantation of AcrySof monofocal IOLs also were assessed.
Results: Corrected and uncorrected distance visual acuity was similar across groups. For uncorrected near and intermediate visual acuity, statistically significant differences were found favouring the SN60D3 group (p<0.0001). Contrast sensitivity was significantly better in monofocal patients at 6 cpd and 18 cpd under various lighting conditions. The Functional Evaluation and the Questionnaire demonstrated that SN60D3 patients achieved significantly higher levels of functional vision and spectacle freedom (p<0.0001).
Conclusion: Despite mildly decreased contrast sensitivity when compared with a monofocal IOL, the SN60D3 provided high patient satisfaction, excellent functional vision, and high rates of spectacle freedom.
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Funding This study was supported by a grant from Alcon Laboratories, Inc. (hereafter called Sponsor) in Fort Worth, Texas (USA). After investigator counsel, the Sponsor provided the protocol. The Sponsor entered study data and employed the third-party statistician who performed the statistical analysis. The Sponsor and the investigators collaborated on the writing effort with full investigator review and guidance of the manuscript. The investigators led the decisions to publish and submit the paper, with Sponsor approval.
Competing interests RJC, MD: Consultant, Alcon Laboratories Inc. DFC, MD: Consultant for AMO, Alcon and Visiogen, but has no direct financial interest in any product mentioned. EDD, MD: Consultant, Alcon, AMO, Bausch and Lomb. SSL: Consultant and Medical Monitor, Alcon. JPM, MD: Consultant, Alcon Laboratories, Inc. KDS, MD, Consultant, Alcon Laboratories, Inc.
Provenance and Peer review Not commissioned; externally peer reviewed.
Ethics approval Ethics approval was provided by RCRC IRB Texas.
Patient consent Obtained.