A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

Detailed Description
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Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Official Title
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A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: ACRYSOF® IQ Extended Depth of Focus IOL
* Device: ACRYSOF® IQ Monofocal IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form; Diagnosed with cataract in both eyes; Planned cataract removal by routine small incision surgery; Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps); Preoperative regular astigmatism of less than 1.0 D. Exclusion Criteria: Pregnancy or lactation current or planned during the course of the study; History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.

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: DFT015<br>ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation | Device: ACRYSOF® IQ Extended Depth of Focus IOL<br>* Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject<br>* Other names: Model DFT015;Procedure: Cataract surgery<br>* IOL bilateral implantation<br>|
| Active Comparator: SN60WF<br>ACRYSOF® IQ Monofocal IOL, bilateral implantation | Device: ACRYSOF® IQ Monofocal IOL<br>* Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject<br>* Other names: Model SN60WF;Procedure: Cataract surgery<br>* IOL bilateral implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) | Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. | Month 3 (70-100 days post second eye implantation) | 
| Percentage of Subjects With Ocular Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned. | Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m) | VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. | Month 3 (70-100 days post second eye implantation) | 
| Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. | Month 3 (70-100 days post second eye implantation) | 
| Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned. | Month 3 (70-100 days post second eye implantation) | 
| Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. | Month 6 (120-180 days post second eye implantation) | 
| Percentage of Subjects Who Respond Never to Question 1 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Any Purpose? | Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) | 
| Percentage of Subjects Who Respond Never to Question 3 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)? | No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) |