Clareon Toric vs Eyhance Toric

Study Overview
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Brief Summary
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The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.

Detailed Description
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This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits.

Official Title
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Clareon Toric vs Eyhance Toric

Conditions
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Cataract, Aphakia

Intervention / Treatment
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* Device: Clareon IOL
* Device: Clareon Toric IOL
* Device: Eyhance IOL
* Device: Eyhance Toric IOL
* Procedure: Phacoemulsification surgery


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Planned bilateral cataract removal by routine small incision phacoemulsification surgery; Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism; Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator; Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce the potential BCDVA to a level worse than 0.2 logMAR; Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome; History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK)); Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame; Other protocol-specified exclusion criteria may apply.

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: Clareon/Clareon Toric<br>Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. | Device: Clareon IOL<br>* Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.<br>* Other names: Model SY60WF;Device: Clareon Toric IOL<br>* Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.<br>* Other names: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as available;Procedure: Phacoemulsification surgery<br>* Cataract removal by routine small incision phacoemulsification surgery<br>|
| Active Comparator: Eyhance/Eyhance Toric<br>Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. | Device: Eyhance IOL<br>* TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.<br>* Other names: Model DIB00;Device: Eyhance Toric IOL<br>* TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.<br>* Other names: Models DIU150, DIU225, DIU300, DIU375 as available;Procedure: Phacoemulsification surgery<br>* Cataract removal by routine small incision phacoemulsification surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean binocular best-corrected distance visual acuity (BCDVA) at 4 meters | Visual Acuity will be tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA will be measured in logarithm minimum angle of resolution (logMAR) units. 0.00 logMar equates to 20/20 Snellen and is considered normal distance eyesight. The eyes will be tested together. | Month 3 postoperative visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataracts, Phacoemulsification, IOL