Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Study Overview
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Brief Summary
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This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization. After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule

Official Title
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Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Conditions
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Cataract, Corneal Astigmatism

Intervention / Treatment
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* Device: IOL Model ZFR00V
* Device: IOL Model ZCB00


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 22 years old have cataracts in both eyes sign the written informed consent be willing and able to comply with examination procedures understand, read and write English to complete informed consent and questionnaires be available for study follow-up visits Exclusion Criteria: currently participating in any other clinical study or have participated in a clinical study during the last 60 days have a certain disease/illness such as poorly-controlled diabetes have certain ocular conditions such as uncontrolled glaucoma Is taking medication that may affect vision Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>Bilateral implantation with investigational IOL Model ZFR00V | Device: IOL Model ZFR00V<br>* Bilateral implantation with Investigational IOL Model ZFR00V<br>|
| Active Comparator: Control<br>Bilateral implantation with control IOL Model ZCB00 | Device: IOL Model ZCB00<br>* Bilateral Implantation with control IOL Model ZCB00<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm | mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months | 6 months (postoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm | mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population | 6 months (postoperative) | 
| Monocular Distance-Corrected Near Visual Acuity at 33 cm | mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months | 6 months postoperative | 
| Monocular Photopic Best-Corrected Distance Visual Acuity | mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population. | 6 months postoperative | 
| Monocular Distance-Corrected Defocus Curve | Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population | 6 months postoperative | 
| Spectacle Wear | Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts none of the time in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative. | 6 months postoperative |