Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations

Abstract

Purpose

To investigate visual and safety outcomes of AcrySof^® IQ PanOptix^® (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies.

Patients and Methods

This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies’ design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4–5 m), intermediate (UCIVA, DCIVA; 60–66 cm), and near (UCNVA, DCNVA; 40 cm) were measured.

Results

The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3–6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4–5 m) to near (–3.00 D; optically equivalent to 33 cm) was observed 3–6 months after TFNT00 implantation. At 3–6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent.

Conclusion

This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.

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Keywords:

• PanOptix
• intraocular lens
• presbyopia
• trifocal lens
• diffractive lens
• pooled analysis

Abbreviations

AE, adverse event; BCDVA, best-corrected distance visual acuity; D, diopter; DCIVA, distance-corrected intermediate visual acuity; DCNVA, distance-corrected near visual acuity; IOL, intraocular lens; logMAR, logarithm of the minimum angle of resolution; MRSE, manifest refraction spherical equivalent; SD standard deviation; SSI, secondary surgical intervention; UCDVA, uncorrected distance visual acuity; UCIVA, uncorrected intermediate visual acuity; UCNVA, uncorrected near visual acuity; VA, visual acuity.

Data Sharing Statement

No further data beyond those provided in this manuscript will be shared.

Acknowledgments

The authors thank Chameleon Communications for editorial assistance in the preparation of the manuscript, with funding from Alcon Research LLC.

Author Contributions

All authors made substantial contributions to the conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agreed to be accountable for all aspects of the work.

Disclosure

Professor Kohnen, Dr Lapid-Gortzak, Professor Bissen-Miyajima and Dr Modi are consultants to, and have received grant support from, Alcon. Professor Kohnen is also consultant for Allergan, Bausch & Lomb, Geuder, Med Update, Santen, Staar, Thieme, Ziemer, and is a consultant, and conducts research for, Alcon/Novartis, Johnson & Johnson, Lensgen, Oculentis, Oculus, Presbia, Schwind, and Zeiss, outside the submitted work. Dr Lapid-Gortzak also reports grants and/or personal fees from CorNeat, Eye Yon Medical, Hanita Lenses, and Zeiss, outside the submitted work. Professor Bissen-Miyajima also reports grants and/or personal fees from Johnson and Johnson Vision, HOYA, Zeiss, and BVI, outside the submitted work. Dr Ramamurthy, Dr Maxwell, and Professor Kim are consultants to Alcon. The authors report no other conflicts of interest in this work.

Additional information

Funding

This work was sponsored by Alcon Research LLC, Fort Worth, Texas. The sponsors participated in the design of the study, data management, data analysis, interpretation of the data, preparation, review, and approval of the manuscript.