Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial

Abstract

Purpose

To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2).

Patients and Methods

A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS^® toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye.

Results

Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported.

Conclusion

Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization.

Trial Registration

German Clinical Trials Register, DRKS00015287.

Keywords:

• astigmatism
• cataract
• IOL rotation
• surgery
• toric IOL

Abbreviations

AE, adverse event; IOL, intraocular lens; Min, minimum; Max, maximum; SAE, serious adverse event; SD, standard deviation.

Data Sharing Statement

The authors do not intend to share individual deidentified participant data. A summarized report with end point data tables based on statistical plan and analysis may be requested directly from the corresponding author for consideration. Access to anonymized data may be granted following review. Content with granted access will be available through email or other appropriate formats and for 3 months, upon review and consideration.

Ethics and Consent Statement

Human participants were included in this study. The IRB/ethics committee of each participating study site approved this study. All research was conducted in accordance with the Declaration of Helsinki. All participants provided signed informed consent.

Acknowledgments

Manuscript development and editorial support was provided by ApotheCom (Yardley, PA) and funded by Johnson & Johnson Surgical Vision, Inc. The following surgeons participated in this clinical program: Robert E. Ang, MD (Asian Eye Institute, Manila, Philippines); Kevin L. Waltz, MD, Rodrigo Quesada, MD, Gabriel Quesada, MD, and John A. Vukich, MD (Clinica Quesada, Centro de Oftalmología y Cirugía Plástica, San Salvador, El Salvador); and Juan F. Batlle, MD, and Rafael Feliz, MD (Laser Center, Santo Domingo, Dominican Republic). Interim data presented at American Academy of Ophthalmology Annual Meeting, October 12–15, 2019, San Francisco, California (oral), and American Society of Cataract and Refractive Surgery Virtual Annual Meeting, May 16–17, 2020 (oral); pooled data from this study and other trials presented at Association for Research in Vision and Ophthalmology Annual Meeting, May 3–7, 2020, Baltimore, Maryland, USA (oral presentation).

Author Contributions

All authors made a significant contribution to the work reported, whether that is 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; have agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.

Disclosure

The authors have made the following disclosures:

J. A. V.: Personal fees and nonfinancial support from Johnson & Johnson Surgical Vision during the conduct of the study; grants and personal fees from Johnson & Johnson Surgical Vision outside the submitted work. R. E. A.: Grants from Johnson & Johnson Surgical Vision during the conduct of the study. B. J. K. S.: Personal fees and nonfinancial support from Johnson & Johnson Surgical Vision during the conduct of the study; personal fees, nonfinancial support, and other (owns shares) from Johnson & Johnson Surgical Vision outside the submitted work. D. P. J.: Employee of Johnson & Johnson Surgical Vision at the time of manuscript preparation. P. J. S.: Personal fees from Johnson & Johnson Surgical Vision during the conduct of the study. J. F. B.: Grants and personal fees from Johnson & Johnson Surgical Vision outside the submitted work. K. L. W.: Honoraria from and research services for Johnson & Johnson Surgical Vision during the conduct of the study; personal fees from and research support and/or consulting relationship with Alcon, BVI, Johnson & Johnson, Rayner, Bausch Health, and Zeiss, outside the submitted work.

Additional information

Funding

This study was supported by Johnson & Johnson Surgical Vision, Inc., which participated in the design and conduct of the study.