The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery. EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery. EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Shasta Eye Medical Group
Redding, California, United States
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, United States
Eye Centers of Florida
Fort Myers, Florida, United States
Mean Percent Cell Change (Preservation of Endothelium)
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Time frame: Baseline, 3 months
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Time frame: 3 months
Percentage of Participants With Anterior Chamber Inflammation
Time frame: 3 months
Percentage of Participants With Device-related Adverse Events Any Visit
Time frame: 3 months
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Newsom Eye and Laser Center
Sebring, Florida, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Comprehensive Eye Care
Washington, Missouri, United States