Clinical Experience With Extended Range of Vision 1-Piece IOL
To evaluate the performance of the new TECNIS Symfony Extended Range of Vision 1-Piece Intraocular Lens (IOL), Model ZXR00 (AMO).
In a prospective, non-randomized, multicenter (EU), open-label clinical study, bilateral implantation of the TECNIS Symfony IOL in 147 patients was evaluated. Healthy patients with cataracts were enrolled after providing informed consent. Standard phaco surgery with or without femtosecond laser assistance was performed. Uncorrected and corrected far visual acuity (VA), uncorrected intermediate, uncorrected and corrected near visual acuity, optical symptoms, patient satisfaction and spectacle independence data were collected at one-month and three-months postoperative. Uncorrected binocular defocus evaluation was done at one-month postoperative.
Three-month results of 140 patients will be presented1. More than 90% achieved uncorrected binocular far and intermediate VA of ≥20/25 while 80 % achieved ≥20/32 near VA (40 cm) which improved by more than 1 line when tested at patient’s best selected distance. Defocus testing at one-month revealed a sustained uncorrected VA of 20/25 or better over more than 1.5 D. Micro-monovision of 0.5 D led to an uncorrected mean visual acuity of 20/25 or better from far through to near. More than 99 % reported no severe halos, 90 % no glare. No device-related adverse event occurred. 94 % or more patients reported being good to completely satisfied with overall and intermediate vision without glasses and during daytime, 83 % or more with their near vision and during nighttime.
The TECNIS Symfony Extended Range of Vision Model ZXR00, provides excellent uncorrected VA for far and intermediate, and functional near vision. Micro-monovision improves near VA without compromising far/intermediate vision. There was low incidence of optical/visual symptoms with high degree of satisfaction/spectacle independence. Caution TECNIS Symfony Extended Range of Vision Model ZXR00 (AMO) is not approved/ for sale in the US. Investigational Device; Limited by Federal/United States Law to Investigational Use.