A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Alcon Research
- Enrollment
- 322
- Locations
- 1
- Primary Endpoint
- Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Time Frame: 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
Time Frame: 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 Outcomes
- Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)(Month 3 (70-100 days post second eye implantation))
- Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm(Month 3 (70-100 days post second eye implantation))
- Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve(Month 3 (70-100 days post second eye implantation))
- Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)(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)?"(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?"(Month 6 (120-180 days post second eye implantation))