Patient Satisfaction With New Extended Range of Vision 1-Piece IOL

Saturday, April 18, 2015: 2:15 PM
Room 5B (San Diego Convention Center)
Beatrice Cochener, MD, PhD

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.