Clinical Ophthalmology (Jan 2023)

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

  • Kohnen T,
  • Lapid-Gortzak R,
  • Ramamurthy D,
  • Bissen-Miyajima H,
  • Maxwell A,
  • Kim TI,
  • Modi S

Journal volume & issue
Vol. Volume 17
pp. 155 – 163

Abstract

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Thomas Kohnen,1 Ruth Lapid-Gortzak,2 Dandapani Ramamurthy,3 Hiroko Bissen-Miyajima,4 Andrew Maxwell,5 Tae-Im Kim,6 Satish Modi7 1Department of Ophthalmology, Goethe-University, Frankfurt, Germany; 2Department of Ophthalmology, Amsterdam University Medical Centers, Amsterdam, Netherlands; 3The Eye Foundation, Coimbatore, Tamil Nadu, India; 4Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan; 5The California Eye Institute, Fresno, CA, USA; 6Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea; 7Seeta Eye Centers, Poughkeepsie, NY, USACorrespondence: Thomas Kohnen, Department of Ophthalmology, Goethe University, Theodor‑Stern-Kai 7, Frankfurt, 60590, Germany, Tel +49 69 6301 6739/ 3945, Fax +49 69 6301 3893, Email [email protected]: 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.Keywords: PanOptix, intraocular lens, presbyopia, trifocal lens, diffractive lens, pooled analysis

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