Clinical Results of a Trifocal Toric Intraocular Lens Using the Holladay Total Surgically Induced Astigmatism Formula for Correcting Low Corneal Astigmatism in Japanese Patients

Abstract

Purpose

To evaluate the effectiveness and safety of the AcrySof IQ PanOptix toric intraocular lens (IOL) with cylinder power of 1.0 D (TFNT20) in a Japanese population with low corneal astigmatism and compare with historical control data for nontoric IOLs.

Setting

Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.

Design

Prospective, single-center study.

Methods

Patients ≥20 years old received TFNT20 IOL in at least 1 eye based on Alcon Toric calculator (Holladay Total surgically induced astigmatism). Effectiveness endpoints included the percentage of eyes with refractive cylinder ≤0.25 D at 30–60 days after surgery, which was compared with a historical control threshold rate of 29.2% for nontoric IOLs and refractive cylinder ≤0.50 D. Monocular uncorrected distance visual acuity (UDVA; 5 m), uncorrected intermediate visual acuity (UIVA; 60 cm), uncorrected near visual acuity (UNVA; 40 cm), and adverse events were evaluated.

Results

Of 41 eyes implanted with TFNT20 IOLs, 37 eyes (90%) achieved refractive cylinder ≤0.25 D at 30–60 days after surgery, demonstrating the superiority of TFNT20 compared with historical data (P<0.0001). Refractive cylinder of ≤0.50 D was achieved by 41 eyes (100%). At 30–60 days, mean ± SD monocular CDVA was −0.15 ± 0.07 logMAR, UDVA was −0.09 ± 0.09 logMAR, UIVA was −0.00 ± 0.07 logMAR, and UNVA was 0.03 ± 0.07 logMAR. Six eyes (15%) had elevated postoperative intraocular pressure, which returned to normal and was not device-related.

Conclusion

TFNT20 IOLs successfully reduced postoperative refractive cylinder and provided good distance, intermediate, and near uncorrected VAs in Japanese patients with low corneal astigmatism.

Keywords:

• trifocal IOL
• toric IOL
• low corneal astigmatism
• toric calculator
• visual acuity

Data Sharing Statement

The data used to support the primary findings of this study are available upon reasonable request from the study sponsor, Alcon Research LLC.

Acknowledgments

The authors thank Lisa Denny, PhD, and Natalia Zhukovskaya, PhD, of ICON plc (Blue Bell, PA, USA) for medical writing support, which was funded by Alcon Vision LLC.

Author Contributions

All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.

Disclosure

Dr Hiroko Bissen-Miyajima received grants and research support from Alcon, Johnson & Johnson Vision, and HOYA, and is a consultant for Alcon, Johnson & Johnson Vision, BVI, and Zeiss. Dr Yuka Ota, Dr Saori Yaguchi, and Dr Kunihiko Nakamura received grants and research support from Alcon Vision LLC, Johnson & Johnson Vision, and HOYA. Noriyuki Sasaki is an employee of Alcon Japan Ltd. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by Alcon Vision LLC. Alcon assisted with the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.