A Clinical Assessment of the Full Range of Functional Vision With Three Tecnis Multifocal IOL 1-Piece Models in Bilateral Cataract Extraction

This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.

• Tecnis Multifocal 1-Piece IOL (Device): +2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00)

Primary outcomes

• Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart. [90 days post-operative]: Uncorrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7cm, and 40.0 cm. Best-corrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7 cm, and 40.0 cm.

Sex: All, ages: 21 Years to any, accepts healthy volunteers

Inclusion Criteria:

* A patient with bilateral cataracts for which phacoemulsification extraction and a posterior multifocal IOL implantation has been planned for both eyes.
* Male or female in good general health, 21 years of age or older at the time of the pre-operative examination and willing to have surgery on their second eye within 7 to 30 days of their first eye.
* A patient must be willing to comply with study instructions, agree to make all office appointments, and complete the entire course of the study.
* A patient has the visual potential of 20/32 or better in each eye after cataract removal and IOL implantation in the judgment of the investigator.
* A patient with a preoperative corneal astigmatism of ≤ 1.5D in each eye \[intraoperative management of corneal astigmatism is permissible, and may include arcuate incision(s) or LRI(s).\]
* A patient has a post-operative astigmatism target of ≤ 0.5D in each eye.
* A patient with clear ocular media other than cataract in each eye.
* A patient with normal OCT of the macula in each eye or a macula judged to be normal by the investigator by clinical examination.
* A patient with naturally dilated pupil sizes of > 3.5mm, evaluated under mesopic illumination.
* A patient must be able to read, comprehend and be willing to give HIPAA and Informed Consent.

Exclusion Criteria:

* A patient with a known pathology that may affect visual acuity (as determined by the investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye.
* A patient with amblyopia or strabismus.
* A patient with capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye.
* A patient with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate as least 3.5mm under mesopic/scotopic conditions) in either eye.
* A patient with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp examination in either eye.
* A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
* A patient with a history of ocular trauma, or ocular surgery in either eye.
* A patient that may, or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period in either eye.
* A patient that had refractive surgery (LASIK, LASEK, RK, PRK, etc.) prior to cataract surgery in either eye.
* A patient with a history of wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended wear daily soft contact lenses within seven days of their scheduled surgery.
* A patient that requires the use of systemic or ocular medications that may affect vision.
* A patient with an uncontrolled acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes, immunocompromised, etc.).
* A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
* A patient currently participating or who has participated within 30 days prior to the start of this study in a drug or other investigational research study.

• Results publication: Dell SJ. Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers. Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020. PMID 33061276

• Steven J Dell, MD, Principal investigator, Dell Laser Consultants