Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population

Study Overview
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Brief Summary
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The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.

Detailed Description
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Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 study visits over a 4-5-month period. Of these 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 3 visit (Day 90-120 post second eye implantation). The second eye implantation will occur 2-30 days after the first implantation.

Official Title
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Clinical Investigation of the Visual Outcomes and Safety After Bilateral Implantation of a Trifocal Presbyopia Correcting IOL in a Korean Population

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: AcrySof IQ PanOptix Multifocal IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requires cataract extraction in both eyes Clear intraocular media other than cataracts in both eyes Calculated lens power between +16.0 and +24.0 diopter (D) Preoperative OR expected postoperative regular corneal astigmatism of < 1.00 D. Exclusion Criteria: Pregnant or lactating Any clinically significant corneal abnormality, per the Investigator's expert medical opinion Previous corneal transplant; previous ocular trauma; previous refractive surgery History of, concurrent, or predisposition to retinal conditions, such as diabetic retinopathy, diabetic macular edema, or macular degeneration.

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: Multifocal IOL<br>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted. | Device: AcrySof IQ PanOptix Multifocal IOL<br>* AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject<br>* Other names: AcrySof® IQ PanOptix™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Defocus Curve at Month 3 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Defocus Curve at Month 1 | The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) | 
| Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] | VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned. | Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation) | 
| Binocular Photopic Best Corrected Contrast Sensitivity With Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) | 
| Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned. | Month 3 (Day 90-120 post second eye implantation) | 
| Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people? | Preoperative and Month 3 (Day 90-120 post second eye implantation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korea, Trifocal, PanOptix, Bilateral implantation, Cataract, Prospective, Single Arm, ACRYSOF, Model TFNT00