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. 2021 Jul 14:15:3001-3016.
doi: 10.2147/OPTH.S309214. eCollection 2021.

Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial

John A Vukich  1 , Robert E Ang  2 , Benjamin J K Straker  3 , Devi Priya Janakiraman  3 , Pamela J Smith  3 , Juan F Batlle  4 , Kevin L Waltz  1
Affiliations

Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial

John A Vukich et al. Clin Ophthalmol. .

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: IOL rotation; astigmatism; cataract; surgery; toric IOL.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Design and characteristic features of the version 1 and version 2 test IOLs and the control IOL (A) and photographic comparison of frosted (left) and unfrosted (right) haptics at high magnification (B).
Figure 2
Figure 2
Bland-Altman plot showing the average of month 1 and month 6 signed orientation versus difference between these time points (month 6 minus month 1 orientation), by IOL. Mean difference and 95% limits of agreement are shown for test and control IOLs combined. Negative values indicate a clockwise difference in orientation between month 1 and month 6 time points.
Figure 3
Figure 3
Boxplot of absolute IOL rotation from operative to postoperative week 1 (A), postoperative month 1 (B), and postoperative month 6 (C).
Figure 4
Figure 4
Mean signed IOL rotation from operative to postoperative day 1, week 1, month 1, and month 6 for the version 1, version 2, and control IOLs. Negative values indicate clockwise rotation, as observed from a slit lamp. Error bars represent 95% CIs of the mean values.
Figure 5
Figure 5
Scatterplots of signed IOL rotation at postoperative day 1 versus week 1 (A), postoperative day 1 versus month 1 (B), and postoperative day 1 versus month 6 (C).
Figure 6
Figure 6
Scatterplot of absolute IOL rotation at postoperative week 1 versus axial length for the version 1, version 2, and control IOLs.
Figure 7
Figure 7
Surgeon responses to the operative questionnaire on ease of IOL handling during implantation for the version 1, version 2, and control IOLs. The operative questionnaire comprised questions on the following: ease of implantation of the IOL into the capsular bag (A); ease of positioning the IOL clockwise at the correct axis (B); ease of positioning the IOL counterclockwise at the correct axis (C); ease of removal of viscoelastic from behind the IOL (D); and whether or not the lens position was impacted by the removal of viscoelastic from behind the IOL (E).
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References

    1. Kessel L, Andresen J, Tendal B, Erngaard D, Flesner P, Hjortdal J. Toric intraocular lenses in the correction of astigmatism during cataract surgery: a systematic review and meta-analysis. Ophthalmology. 2016;12:275–286. - PubMed
    1. Ma JJ, Tseng SS. Simple method for accurate alignment in toric phakic and aphakic intraocular lens implantation. J Cataract Refract Surg. 2008;34:1631–1636. doi:10.1016/j.jcrs.2008.04.041 - DOI - PubMed
    1. Schartmuller D, Schriefl S, Schwarzenbacher L, Leydolt C, Menapace R. True rotational stability of a single-piece hydrophobic intraocular lens. Br J Ophthalmol. 2019;103(2):186–190. doi:10.1136/bjophthalmol-2017-311797 - DOI - PubMed
    1. Hahn U, Krummenauer F, Schmickler S, Koch J. Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT). BMC Ophthalmol. 2019;19:143. doi:10.1186/s12886-019-1147-5 - DOI - PMC - PubMed
    1. The TECNIS® Toric 1-Piece (IOL). Santa Ana, CA: Johnson & Johnson Vision, Inc; 2020. Available from: https://www.precisionlens.net/wp-content/uploads/JJ-Tecnis-Toric-DFU.pdf. Accessed June29, 2020.

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