Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Study Overview
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Brief Summary
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This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Official Title
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Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses

Conditions
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Cataract

Intervention / Treatment
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* Device: Tecnis Eyhance
* Device: Tecnis 1 piece 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 Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source Potential for postoperative best corrected visual acuity of 20/30 Snellen or better Corneal astigmatism parameters: Normal corneal topography and no irregular corneal astigmatism Postoperative astigmatism can be surgically managed to be less than 1 D in each eye Clear intraocular media other than cataract in each eye Availability, willingness, ability, 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: Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) 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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No

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: Study Lens<br>Tecnis Eyhance | Device: Tecnis Eyhance<br>* Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.<br>|
| Active Comparator: Control Lens<br>Tecnis 1 piece IOL (Intraocular lens) | Device: Tecnis 1 piece IOL<br>* Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups | 6 months |