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Randomized Controlled Trial
. 2023 Aug 1;49(8):840-847.
doi: 10.1097/j.jcrs.0000000000001205.

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial

Daniel H Chang  1 , Jerry G Hu, Robert P Lehmann, Vance M Thompson, Linda H Tsai, Eugenia K Thomas
Affiliations
Randomized Controlled Trial

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial

Daniel H Chang et al. J Cataract Refract Surg. .

Abstract

Purpose: To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients.

Setting: Multicenter clinical setting.

Design: Prospective, randomized, subject/evaluator-masked clinical trial.

Methods: Cataract patients aged ≥22 years were randomly assigned 1:1 to bilateral implantation with ZFR00V or ZCB00. Key end points at 6 months postsurgery included monocular and binocular visual acuities at 4 m, 66 cm, 33 cm, and/or 40 cm, binocular distance-corrected defocus testing, patient-reported outcomes, and safety.

Results: 272 patients were implanted with ZFR00V (135) or ZCB00 (137). At 6 months, 83/131 (63.4%) ZFR00V patients demonstrated 20/25 or better combined monocular distance-corrected vision at far, intermediate, or near, compared with 5/130 (3.8%) ZCB00 patients. ZFR00V demonstrated excellent binocular uncorrected vision at intermediate (0.022 logMAR) and distance-corrected vision at 40 cm (0.047 logMAR). Strong ZFR00V performance persisted under mesopic conditions (0.244 logMAR or ∼20/32 Snellen), where improvement over ZCB00 with distance-corrected vision at near was 3.5 lines. ZFR00V provided a broad range of functional vision (20/32 or better) through -3.5 diopters of defocus (29 cm). Most ZFR00V patients reported no spectacle wear overall (93.1%) or at all 4 viewing distances combined (87.8%), and 55.7% qualified as completely spectacle independent. Relatively low proportions of ZFR00V patients reported being very/extremely bothered by halos (13.7%), starbursts (11.5%), or night glare (8.4%). The safety profile was similar between IOL groups.

Conclusions: TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.

Trial registration: ClinicalTrials.gov NCT03949335.

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References

    1. U.S. Food and Drug Administration. TECNIS Synergy Intraocular Lens (IOL) (Model ZFR00V), TECNIS Synergy Toric II IOL (Models ZFW150, ZFW225, zZFW300, ZFW375), TECNIS Synergy IOL with TECNIS Simplicity Delivery System (Model DFR00V), TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery System (Models DFW150, DFW225, DFW300, DFW375): P980040/S124. Silver Spring, MD: U.S. Food and Drug Administration; 2021
    1. Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg 2022;48:288–297
    1. de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev 2016;12:CD003169
    1. Dick HB, Ang R, Corbett D, Hoffmann P, Tetz M, Villarrubia A, Palomino C, Castillo-Gomez A, Tsai L, Thomas EK, Janakiraman P. Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens. J Cataract Refract Surg 2022;48:1270–1276
    1. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED). Silver Spring, MD: U.S. Food and Drug Administration; 2022. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/P980040S124B.pdf . Accessed August 7, 2022

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