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

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: ACRYSOF® IQ Monofocal IOL
Device: ACRYSOF® IQ Extended Depth of Focus IOL
Procedure: Cataract surgery

Registration Number: NCT03010254

Lead Sponsor: Alcon Research

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 322

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SN60WF	ACRYSOF® IQ Monofocal IOL	ACRYSOF® IQ Monofocal IOL, bilateral implantation
DFT015	ACRYSOF® IQ Extended Depth of Focus IOL	ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
DFT015	Cataract surgery	ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
SN60WF	Cataract surgery	ACRYSOF® IQ Monofocal IOL, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)	Month 3 (70-100 days post second eye implantation)	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.
Percentage of Subjects With Ocular Adverse Events	Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)	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.

Secondary Outcome Measures

Name	Time	Method
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)	Month 3 (70-100 days post second eye implantation)	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.
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	Month 3 (70-100 days post second eye implantation)	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.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve	Month 3 (70-100 days post second eye implantation)	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.
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)	Month 6 (120-180 days post second eye implantation)	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.
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)?"	Month 6 (120-180 days post second eye implantation)	No formal statistical hypothesis testing was planned.
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"	Month 6 (120-180 days post second eye implantation)	Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.