TY - JOUR
T1 - Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens
T2 - A Worldwide Pooled Analysis of Prospective Clinical Investigations
AU - Kohnen, Thomas
AU - Lapid-Gortzak, Ruth
AU - Ramamurthy, Dandapani
AU - Bissen-Miyajima, Hiroko
AU - Maxwell, Andrew
AU - Kim, Tae-Im
AU - Modi, Satish
N1 - Funding Information: 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. Publisher Copyright: © 2023 Kohnen et al.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - PanOptix
KW - diffractive lens
KW - intraocular lens
KW - pooled analysis
KW - presbyopia
KW - trifocal lens
UR - http://www.scopus.com/inward/record.url?scp=85146480229&partnerID=8YFLogxK
U2 - https://doi.org/10.2147/OPTH.S377234
DO - https://doi.org/10.2147/OPTH.S377234
M3 - Article
C2 - 36647516
SN - 1177-5467
VL - 17
SP - 155
EP - 163
JO - Clinical Ophthalmology
JF - Clinical Ophthalmology
ER -