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

Abstract

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

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Keywords: IOL misalignment; lens rotation; residual astigmatism; toric IOL.

Figure 1

(A) Final position of the IOL following surgery. (B) Postoperative retro-illuminated slit lamp photograph of the same eye with visualization of at least one IOL axis mark on each side, iris, limbal and scleral details.

Figure 2

(A) Percentage distribution of absolute lens rotation at the 1-day and 3-month visits relative to intraoperative position. (B) Percentage distribution of rotational stability between 1-day and 3-month visits with valid axis data at both visits.

Figure 3

(A) Distribution of number of eyes implanted with Tecnis toric II models (Model ZCU). (B) Percentages of eyes with absolute lens rotation of ≤5° at the 1-day and 3-month visits relative to intraoperative position. (C) Mean and standard deviation of absolute lens rotation measured at the 1-day visit by lens model. (D) Mean and standard deviation of absolute lens rotation measured at the 3-month visit by lens model.

Figure 4

(A) Cumulative Snellen uncorrected (UDVA) and corrected (CDVA) distance visual acuity distribution for eyes at 3 months. (B) Percentage distribution of difference between achieved vs planned spherical equivalent refraction at 3 months. (C) Percentage distribution residual refractive cylinder at 3 months.

Figure 5

(A) Surgeon satisfaction of overall outcomes, rotational stability, and uncorrected distance visual acuity for all implanted eyes. (B) Patient satisfaction in bilaterally implanted study subjects for distance vision without glasses or contact lenses at 3-months. (C) Patient satisfaction in bilaterally implanted subjects on how often they felt the need to wear eyeglasses or contact lenses to improve distance vision at 3-months.