Clinical Investigation of the Next-Generation Intraocular Lenses

Study Overview
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Brief Summary
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This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Investigational Intraocular Lens Device #1: Model ZFR00
* Device: Investigational Intraocular Lens Device #1: Model ZYR00
* Device: TECNIS Multifocal Intraocular Lens: Model ZLB00


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 22 years of age Bilateral cataracts for which posterior chamber IOL implantation has been planned Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source Potential for postoperative BCDVA of 20/30 Snellen or better Corneal astigmatism: Normal corneal topography Preoperative corneal astigmatism of 1.00 D or less in both eyes Clear intraocular media other than cataract in each eye 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 in English Exclusion Criteria: Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D 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. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcome or increase risk to the subject, are acceptable. 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 (per procedure outlined in Section 10.3) 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 (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study 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 during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery) 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 outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable. Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.) 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 60 days prior to preoperative visit in any other clinical trial Desire for monovision correction

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Lens Device #1<br>Investigational Intraocular Lens Device #1: Model ZFR00 | Device: Investigational Intraocular Lens Device #1: Model ZFR00<br>* IOL replaces the natural lens removed during cataract surgery.<br>|
| Experimental: Investigational Lens Device #2<br>Investigational Intraocular Lens Device #1: Model ZYR00 | Device: Investigational Intraocular Lens Device #1: Model ZYR00<br>* IOL replaces the natural lens removed during cataract surgery.<br>|
| Active Comparator: Control Device<br>Control TECNIS Multifocal Intraocular Lens Model ZLB00 | Device: TECNIS Multifocal Intraocular Lens: Model ZLB00<br>* IOL replaces the natural lens removed during cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Corrected Intermediate Visual Acuity | Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only. | 1 month |