A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

Study Overview
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Brief Summary
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This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).

Official Title
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A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Eyhance™ Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DIU and the TECNIS Synergy® Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DFW to the TECNIS® Toric Intraocular Lens Model Series ZCT

Conditions
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Cataract

Intervention / Treatment
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* Device: Model DIU
* Device: Model DFW
* Device: Model ZCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes: Male or female at least 22 years of age Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s) Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative 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. Exclusion Criteria: Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes: Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR) Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR) Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm) Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures) Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject 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. Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

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: Eyhance Toric II IOL<br>Model DIU | Device: Model DIU<br>* Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.<br>|
| Experimental: TECNIS Synergy Toric II<br>Model DFW | Device: Model DFW<br>* Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.<br>|
| Active Comparator: TECNIS Toric 1-Piece IOL<br>Model ZCT | Device: Model ZCT<br>* Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational Stability of IOL | The percentage of eyes with rotational stability of the IOL at postoperative 6 months | 6-months post-operative |