Clinical Investigation of the Next-Generation Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Official Title
-----------------
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
* Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
* Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral cataracts Potential for postoperative BCDVA of 20/30 Snellen or better Corneal astigmatism of 1.00 D or less in both eyes Normal corneal topography Clear intraocular media other than cataract in each eye Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries Exclusion Criteria: Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils) Irregular corneal astigmatism Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study Inability to achieve keratometric stability for contact lens wearers Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject Subjects with diagnosed degenerative visual disorders Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects Use of systemic or ocular medications that may affect vision Prior, current, or anticipated use of tamsulosin or silodosin Poorly-controlled diabetes Acute, chronic, or uncontrolled systemic or ocular disease or illness Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial Desire for monovision correction

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigational Lens Device #1<br>Investigational Intraocular Lens Device #1: Tecnis Model ZHR00 | Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00<br>* Intraocular lens replaces the natural lens removed during cataract surgery.<br>|
| Other: Investigational Lens Device #2<br>Investigational Intraocular Lens Device #2: Tecnis Model ZQR00 | Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00<br>* Intraocular lens replaces the natural lens removed during cataract surgery.<br>|
| Other: Control Device<br>Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 | Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00<br>* Intraocular lens replaces the natural lens removed during cataract surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative | 1 month postoperative | 
| Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | 6 months postoperative | 
| Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | 6 months postoperative |