Reproducibility of the Magnitude of Lens Rotation Following Implantation of a Toric Intraocular Lens with Modified Haptics

Abstract

Purpose To evaluate the reproducibility of magnitude of postoperative IOL rotation following implantation of a toric intraocular lens (IOL) with modified haptics, in comparison with a Proof-of-Concept (POC) study of prototype IOLs featuring the same haptic design. Patients and Methods A post-market, prospective, multicenter, single-arm, open-label clinical study was conducted. TECNIS Toric II IOL (Johnson & Johnson Vision, Irvine, CA, USA, Models ZCU150 to 600) were implanted in 125 subjects and evaluated at 1-day and 1-week postoperatively. An objective photographic method was used to determine postoperative IOL rotation. Uncorrected distance visual acuity (UCDVA), postoperative astigmatism, and surgeon satisfaction were also assessed. Rotation data were compared to the POC study in which two prototype non-toric monofocal IOLs, one with the same haptic design as Model ZCU, were studied. Results Mean absolute rotation was 0.82° ± 1.0° and 0.84° ± 0.92°at 1-day and 1-week visits, respectively. The percentage of eyes with ≤5° of absolute rotation was 98.9% and 99.5% at the 1-day and 1-week visits, respectively. The magnitude of rotation was similar to the POC study prototype IOLs. At 1-week, mean monocular UCDVA was 0.026 ± 0.135 (~20/21) logMAR and mean residual manifest refractive cylinder was 0.30 D ± 0.35 D. The mean signed axis difference (postoperative minus operative) of the TECNIS Toric II IOL was 0.23° ± 1.27° at 1-day and −0.07° ± 1.25° at 1-week, indicating a clockwise drift. At 1-week, surgeons were very satisfied or satisfied with overall clinical outcomes and rotational stability in 98% of implanted eyes. Conclusion The TECNIS Toric II IOL, with frosted, squared haptics, demonstrated low magnitude of postoperative IOL rotation, excellent uncorrected distance vision, and minimal residual astigmatism. The POC study design was supported, demonstrating that prototype non-toric monofocal IOLs can predict clinical performance of toric IOLs with the same haptic design.

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

“…Procedures for calculating IOL power and axis alignment are detailed in a prior publication. 10 Briefly, preoperative keratometry and biometry data including axial length, incision location, spherical equivalent IOL power, and the surgeon’s estimated surgically induced corneal astigmatism were used as inputs for the TECNIS Toric Calculator ( www.TecnisToricCalc.com ) or the surgeon’s preferred Toric Calculator. The investigators were instructed to use their standard IOL axis marking and small-incision, phacoemulsification, cataract extraction surgical technique.…”

“…Short-term rotational stability, defined as 1-day and 1-week postoperatively, and clinical performance of the Tecnis Toric II (Model ZCU) IOL from this were described in a previous publication. 10 In the current manuscript, short- and long-term lens rotation, visual acuity, manifest refraction, and patient and surgeon satisfaction were evaluated over a 3-month period following implantation.…”

Comparison of Visual Efficacy and Patient’s Satisfaction between Two Toric IOLs, Enhanced for Intermediate Vision and Monofocal

“…19,20 TECNIS Eyhance Toric II IOL has frosted haptics to increase surface friction between the capsular bag and the lens haptics, as well as a constant power pro le optic to improve intermediate vision. 10,[21][22][23] Takaku R et al reported that toric II IOL demonstrated higher rotational stability than toric I IOL with lower residual manifest astigmatism (p = 0.018), lower axis misalignment (p = 0.04), less incidence of misalignment > 10º (p = 0.0044), and a smaller degree of prediction errors (p = 0.043). 9 Osawa R. et al also reported the same results with rotational stability and an incidence of misalignment > 10º.…”

Repositioning Rates of Toric IOLs Implanted in Cataract Surgery Patients: A Retrospective Chart Review

“… 24 The statistically significantly lower repositioning rate of the Tecnis Toric II vs the Tecnis Toric I IOLs in the present study corroborates this and other findings of a very low rate of rotation with the newer lens platform. 3 , 23 , 24 …”

“… 2 Maximum rotation of toric IOLs occurs in the early postoperative period, usually within the first few hours of cataract surgery, and very little rotation occurs after 1 week postoperatively. 2 , 3 Various modifiable and non-modifiable risk factors, including incomplete removal of ophthalmic viscosurgical devices; decentered, non-circular, or unusually large capsulorhexis; longer axial length/high myopia; larger capsular bag size; and fluctuations in intraocular pressure, have been found to be associated with an increased likelihood of toric IOL rotation. 4–7 IOL manufacturers have introduced a variety of innovations in IOL material and design to improve postoperative IOL stability and prevent IOL rotation even in the presence of risk factors.…”