Clinical Investigation of Expanded Designs of a Multifocal IOL

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.

Official Title
-----------------
Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL

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

Intervention / Treatment
-----------------
* Device: Tecnis Multifocal Intraocular Lens
* Device: Monofocal Intraocular Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 18 years of age Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source Potential for postoperative best-corrected visual acuity of 20/25 or better Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism Clear intraocular media, other than cataract Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries Ability to understand and respond to a questionnaire verbally administered in English Exclusion Criteria: Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes Prior 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 of 20/30 or worse during the study Inability to achieve keratometric stability for contact lens wearers Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects Use of systemic or ocular medications that may affect vision Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) Poorly-controlled diabetes Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable. Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) 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 30 days prior to preoperative visit in any other clinical trial Desire for monovision correction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tecnis Multifocal Intraocular lens #1<br>A low diopter add multifocal intraocular lens | Device: Tecnis Multifocal Intraocular Lens<br> <br> |
| Experimental: Tecnis Multifocal Intraocular Lens #2<br>A low diopter add multifocal intraocular lens | Device: Tecnis Multifocal Intraocular Lens<br> <br> |
| Active Comparator: Monofocal Intraocular Lens<br>Commercially available monofocal intraocular lens (IOL) | Device: Monofocal Intraocular Lens<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diopter Range With VA of 20/40 or Better | Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy. * The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively. | six months | 
| Spectacle Independence | Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, IOL, intraocular lens