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Clinical evaluation of a new 1-piece IOL designed to extend range of vision: paired-eye study

Poster Details

First Author: R.Steinert USA

Co Author(s):    K. Waltz   M. Fajardo-Baide           

Abstract Details



Purpose:

To evaluate the clinical performance of the new TECNIS® Symfony Extended Range of Vision 1-Piece Intraocular Lens (IOL), Model ZXR00 (Abbott Medical Optics Inc.), as compared to a monofocal IOL (TECNIS 1-Piece IOL, Model ZCB00).

Setting:

Private practice setting in San Pedro Sula (Honduras)

Methods:

In a prospective, single-center study, 23 cataract subjects were implanted with the TECNIS Symfony Extended Range of Vision 1-Piece IOL, Model ZXR00 (AMO), in one eye (randomized) and a monofocal IOL, Model ZCB00, in the fellow eye after obtaining informed consent. Follow-up visits took place 1 week after surgery for each eye and 1 month and 3 months after surgery for both eyes. Key evaluation criteria included uncorrected and corrected visual acuity at far, distance-corrected visual acuity at intermediate (66 cm) and near (40 cm), contrast sensitivity, defocus testing, and optical/visual symptoms.

Results:

Far visual acuities were comparable between the Model ZXR00 and ZCB00 IOLs. However, monocular visual acuities were significantly better at intermediate (0.09 vs. 0.32 LogMAR) and near (0.34 vs. 0.49 LogMAR) with Model ZXR00 when compared to ZCB00 (p<0.05), with a ≥1.5-line improvement. Contrast sensitivity (mesopic with glare) for the ZXR00 IOL was found to be comparable to that with Model ZCB00. The monocular defocus curve for Model ZXR00 demonstrated a clinically significant increase in depth of focus over Model ZCB00, as evidenced by sustaining 20/40 or better acuity through -2.4 D of defocus and ≥2 lines of visual acuity improvement through a range of defocus between -1.5 and -3.0 D. There was no detectable difference in reported difficulty with halos and glare between the ZXR00 and ZCB00 lenses (p>0.05).

Conclusions:

The results of this clinical study demonstrate that the TECNIS Symfony Model ZXR00 IOL provides distance vision and contrast sensitivity comparable to that of a monofocal IOL and significantly improved intermediate and near vision without significant impact from halos and glare. FINANCIAL INTEREST: One of more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One of more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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