Patient Satisfaction With New Extended Range of Vision 1-Piece IOL
Purpose
To evaluate satisfaction and spectacle independence of patients after bilateral implantation of the new TECNIS Symfony Extended Range of Vision 1-Piece Intraocular Lens (IOL), Model ZXR00 (AMO).
Methods
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/without femtosecond laser assistance was performed. Uncorrected and corrected visual acuity at different distances and optical visual disturbances were examined at the one-month and three-month examinations. In addition, a subjective questionnaire was administered to evaluate patient satisfaction and spectacle independence. Defocus evaluation was done at one-month postoperative. Complications and adverse events were also collected.
Results
Three-month results1 of 140 patients revealed binocular uncorrected VA of ≥20/25 over more than 1.5 D of defocus. 95 % and more patients reported comfortable visual function w/o glasses for far/intermediate, 76 % w/o glasses at near. 70% of subjects reported using glasses never/rarely, with 38% reporting using it for reading. Micro-monovision outcomes improved uncorrected near vision and reduced spectacle usage. More than 90 % reported no day/night glare and no/mild halos. More than 95% reported acceptable to very easy to perform activities w/o glasses during day/night including watching TV and using iPads/PCs. No device-related adverse event occurred.
Conclusion
The TECNIS Symfony Extended Range of Vision Model ZXR00, provides high levels of ease in performing activities at day/night without glasses and high degree of satisfaction. Results showed high spectacle independence and excellent uncorrected VA for far/intermediate, and functional near vision with low incidence of optical/visual symptoms. 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.