Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Detailed Description
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Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period. This study will be conducted in Japan.

Official Title
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Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

Conditions
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Aphakia, Corneal Astigmatism

Intervention / Treatment
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* Device: ACRYSOF IQ PanOptix Toric Trifocal IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye. Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Irregular corneal astigmatism. History of anterior segment, posterior segment, or optic nerve pathology. History of previous intraocular or corneal (refractive or trauma related) surgery. Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK). Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PanOptix Toric Trifocal IOL<br>ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted. | Device: ACRYSOF IQ PanOptix Toric Trifocal IOL<br>* Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism<br>* Other names: Model TFNT20;Procedure: Cataract surgery<br>* Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. | Day 30-60 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | Day 30-60 postoperative | 
| Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60) | A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol. | Day 30-60 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toric, Cataract, Intraocular lens, Astigmatism