Clinical Investigation of the Next Generation Intraocular Lens

Study Overview
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Brief Summary
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An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Detailed Description
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The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

Official Title
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Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00

Conditions
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Cataract

Intervention / Treatment
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* Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
* Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL


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 Corneal astigmatism: Normal corneal topography Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits 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: 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, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs Poorly-controlled diabetes 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 Device: Next Generation TECNIS IOL<br>Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL | Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL<br>* Intraocular lens replaces the natural lens removed during cataract surgery.<br>|
| Active Comparator: Control Device: TECNIS Monofocal IOL<br>Control Monofocal Intraocular Lens: TECNIS Monofocal IOL | Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL<br>* Intraocular lens 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 |
| --- | --- | --- |
| Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | 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. | 6 months (postoperative) | 
| Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only. | 6 months (postoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only. | 6 months (postoperative) | 
| Overall Spectacle Wear | Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of none of the time and the combined reports of a little of the time, some of the time, most of the time, or all of the time. | 6 months (postoperative) |