The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.
Wolstan & Goldberg Eye Associates
Torrance, California, United States
RECRUITINGMoyes Eye Center
Kansas City, Missouri, United States
RECRUITINGCarolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual Acuity (VA) will be assessed for both eyes together (binocular) using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.
Time frame: Month 1 and Month 6 postoperative
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Houston Eye Associates
Houston, Texas, United States
RECRUITINGThe Eye Institute of Utah
Salt Lake City, Utah, United States
RECRUITING