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Depth-of-focus, visual outcomes, and spectacle independence of a new diffractive presbyopia-correcting intraocular lens

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First Author: A.Villarrubia Cuadrado SPAIN

Co Author(s):    R. Ang   C. Palomino   A. Castillo   P. Janakiraman   N. Thomas   C. Sefton     

Abstract Details

Purpose:

A new diffractive presbyopia-correcting IOL (PCIOL) has been developed with a hybrid optical design that combines the benefits of both multifocal and extended depth-of-focus technologies. Clinical outcomes of this new PCIOL were compared to that of a trifocal IOL at three- and six-months postoperative.

Setting:

Multi-center clinical trial in private clinics

Methods:

This was a prospective, bilateral, multi-center, clinical trial with planned follow-up through 12 months. Adults requiring cataract surgery or refractive lensectomy with < 1.0 D of predicted post-operative corneal astigmatism in both eyes were randomized (2:1 ratio) to PCIOL (TECNIS Synergy IOL Model ZFR00V, test) or the trifocal IOL (Model TFNT00) and targeted for emmetropia. Key postoperative endpoints were mean binocular distance corrected depth of focus (diopters of negative defocus with at least 0.2 logMAR visual acuity) and distance-corrected visual acuity (DCVA) at far and near (40 cm and 33 cm). Subject responses to a spectacle independence questionnaire were included.

Results:

Interim data from 83 subjects were available at three months (test n = 57, trifocal n = 26). The test IOL maintained 0.2 logMAR acuity (20/32) through 3.5 D of defocus vs -3.0 D for the trifocal IOL. Mean binocular DCVA at far, 40 cm, and 33 cm was -0.07, 0.01, and 0.06 logMAR, respectively vs -0.02, 0.06, and 0.15 logMAR for the trifocal IOL. Test subjects reported less spectacle wear, where more than 90% reported “none of the time” overall for far, intermediate and near distances, in contrast to trifocal subjects (less than 90% at each distance).

Conclusions:

The new presbyopia-correcting IOL demonstrated exceptional visual performance from distance to near. The new PCIOL Model ZFR00V provided benefit over the Model TFNT00 trifocal IOL with a broad range of continuous vision through 33 cm and a decreased frequency of spectacle wear at all distances.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation