Post-Market Evaluation of Rotational Stability and Visual Performance of a New Toric Intraocular Lens with Frosted...

To evaluate 3-month rotational stability, and visual and refractive outcomes of a toric intraocular lens (IOL) with frosted haptics.

A post-market, prospective, multi-center, single-arm, open-label study conducted at seven clinical sites in the United States. Two hundred and two eyes of 133 subjects with unilateral or bilateral cataracts and corneal astigmatism were implanted with the Tecnis Toric II IOL, Models ZCU150 to 600 (Johnson & Johnson Surgical Vision, Inc.). Lens axis misalignment/rotation, visual acuity, manifest refraction, and surgeon and patient satisfaction were evaluated 3 months postoperatively. Lens rotation was determined with operative and postoperative visit photographs and was analyzed by two independent masked analysts.

Mean absolute lens rotation was 0.82° ± 1.00° and 0.94° ± 0.71° at 1 day (n = 189 eyes) and 3 months (n = 185 eyes), respectively. Absolute lens rotation was ≤5° in 98.9% and 100% of eyes at 1 day and 3 months, respectively. At 3 months, postoperative monocular uncorrected and corrected distance visual acuities were 0.004 ± 0.115 LogMAR (20/20) and -0.066 ± 0.092 LogMAR (20/17), mean spherical equivalent was -0.25 D ± 0.35 D and residual refractive cylinder was +0.27 D ± 0.33 D. Surgeons were satisfied/very satisfied with overall clinical outcomes and rotational stability in 99% of eyes, and with uncorrected distance vision in 98.5% of eyes.

The study results demonstrate that the Tecnis Toric II IOL has excellent rotational stability with a high percentage of study eyes being within 5° of intended orientation. The study lens demonstrated excellent uncorrected distance visual acuity, reduction of cylinder, and exceptional patient and surgeon satisfaction.