A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus 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 ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

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 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Official Title
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A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus 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: Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) Preoperative regular astigmatism of < 1.0 D in both eyes Clear intraocular media other than cataract Diagnosed with cataract in both eyes Planned cataract removal by routine small incision surgery Calculated lens power between 18.0 and 25.0 diopter (D) [when targeted for emmetropia (0.0 D)] Willing and able to complete all required postoperative visits Able to comprehend and sign an ethics committee-approved statement of informed consent Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion. Exclusion Criteria: History of eye pathology and/or inflammation, as specified in the protocol Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion History of previous intraocular or corneal surgery Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.

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.<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) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA 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 6 (120-180 days post second eye implantation) | 
| Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane | VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic 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 6 (120-180 days post second eye implantation) | 
| Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve | Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. 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 6 (120-180 days post second eye implantation) | 
| Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better | VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA 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. No formal statistical hypothesis testing was planned. | Month 6 (120-180 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 in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the 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) | 
| Mesopic Contrast Sensitivity | 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 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (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. No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane | VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm 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 6 (120-180 days post second eye implantation) | 
| Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See? | The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy. | Month 6 (120-180 days post second eye implantation) | 
| Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane | VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA 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. No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) | 
| Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) | VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA 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. No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) | 
| Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned. | Month 6 (120-180 days post second eye implantation) |