Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

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 AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Detailed Description
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Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Official Title
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Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ PanOptix™ IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and sign a statement of informed consent; Willing and able to complete all required postoperative visits; Cataracts in both eyes with planned cataract removal by phacoemulsification; Calculated lens power within the available range; Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes; Able to undergo second eye surgery within 30 days of the first eye surgery. Exclusion Criteria: Significant irregular corneal aberration as demonstrated by corneal topography; Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity; Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses; Previous refractive surgery; Diabetic retinopathy Other eye conditions as specified in the protocol Pregnant.

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 IOL<br>AcrySof® IQ PanOptix™ IOL, bilateral implantation | Device: AcrySof® IQ PanOptix™ IOL<br>* Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient<br>* Other names: Model TFNT00;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | 
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | 
| Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trifocal IOL