Prospective Evaluation of the Tecnis Symfony Intraocular Lens (IOL)

Symfony Extended Range of Vision IOL was approved by the FDA for commercial use in the United States in August 2016 demonstrating reasonable assurance of safety and effectiveness (PMA # P980040 S065). The Symfony IOL diffracts light in a way that allows an extended range of focus, rather than focusing light at distinct points. Monofocal IOLs have one distinct focus, which can be set by the surgeon for distance, intermediate, or near. Multifocal IOLs have two distinct foci for light, at distance and intermediate or near. The proposed optics of the Symfony are geared toward elongating the eye's focus, rather than producing two distinct focal points. This elongated focus allows a more continuous spectrum of sharp vision from distance through intermediate and to near points. Additionally, because light is not focused at two distinct points, glare and halos should not be as noticeable.

The Symfony IOL offers many advantages to patients, including the absence of a blurry zone of vision between two distinct focal points. With this comes the possibility of reduced glare and halos. Additionally, the extended depth of focus, which is more consistent with accommodating lenses, is not dependent on postoperative movement of the IOL.

An important consideration when selecting this lens is the patient's desired quality of near vision. The defocus curve of the Symfony lens shows vision between 20/15 and 20/20 from distance to approximately 66 cm (2 ft). Vision ranges from 20/20 to 20/30 in the intermediate range of vision until about 50 cm (19 in) and then drops to 20/40 at 40 cm (1 ft). For patients looking for crisp vision for close reading, this lens may not meet expectations.

This study will simply involve following patients who are implanted with the Tecnis Symfony Extended Range of Vision IOL. No clinical testing will be performed on the patients other than those routinely performed by the examining clinician. The only non-routine aspect to the study is the administration of questionnaires to evaluate symptoms and satisfaction. Thus it appears that this study introduces no extra risk to the patient over and above that of the underlying cataract surgery.

The objectives of this single surgical site clinical study are to study the subjective visual symptoms, spectacle independence at various distances and patient satisfaction after bilateral implantation of the Tecnis Symfony Extended Range of Vision IOL in a co-managed care environment (Ophthalmologists and Optometrists).

The patient population for this clinical study will be 200 bilaterally implanted Symfony IOL patients from 10 optometric practices who fit the inclusion/exclusion criteria for this study determined at 1 month postoperatively and were referred to a single surgical site.

This study will be a prospective clinical investigation. The study endpoint will be at 3 months postoperatively. Subjects will be recruited from the referring optometrist's current patient population. Subjects will be enrolled into the study in a sequential manner only after it has been determined that they are qualified according to the Clinical Protocol inclusion and exclusion criteria. The study will involve a single surgical site (Principal Investigator and Surgeon Co-Investigator) and 10 co-managing optometric referring sites (Co-Investigators). Informed consent, testing study subject questionnaire administration will be conducted at the co-managing optometric sites. Surgery will be performed at the single surgical site.

The incidence of subjective visual symptoms, spectacle independence at various distances and patient satisfaction will be tabulated for each center and for the population as a whole