EYEFILL® C. -US Viscoelastic Clinical Investigation
- Conditions
- Cataract
- Interventions
- Device: Healon® Viscoelastic (CONTROL)Device: EYEFILL® C.-US Viscoelastic
- Registration Number
- NCT02024711
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 262
- Any race
- Older than 21 years
- Cataract requiring cataract extraction in at least 1 eye
- Clear intraocular media other than cataract
- Able to provide written informed consent
- Able and willing to comply with required follow-up schedule
- Competent to understand the procedure and the actions asked of him/her as a research subject
- Monocular
- Ocular infection
- History of glaucoma, Ocular Hypertension (IOP > 21 mmHg) likely to require IOP lowering medications, ocular condition requiring IOP lowering medication, condition preventing reliable Goldmann applanation tonometry, known steroid responder
- Previous intraocular surgery in the operative eye
- Previous serious corneal disease or known endothelial cell loss / damage (in operative eye)
- History of chronic or recurrent inflammatory eye disease (in operative eye)
- Evidence of retinal vascular disease (in operative eye)
- Uncontrolled diabetes or proliferative diabetic retinopathy
- Acute or chronic disease or illness that would increase the operative risk
- Allergy to anesthetics or other postoperative medications
- Known hypersensitivity to sodium hyaluronate or other components in viscoelastic
- Patient in any other clinical trial within the 30 days prior to the start of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healon® Viscoelastic (CONTROL) Healon® Viscoelastic (CONTROL) 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. EYEFILL® C.-US Viscoelastic EYEFILL® C.-US Viscoelastic 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.
- Primary Outcome Measures
Name Time Method Mean Percent Cell Change (Preservation of Endothelium) Baseline, 3 months Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Anterior Chamber Inflammation 3 months Percentage of Participants With Device-related Adverse Events Any Visit 3 months Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit 3 months
Trial Locations
- Locations (8)
Shasta Eye Medical Group
🇺🇸Redding, California, United States
Great Lakes Eye Care
🇺🇸Saint Joseph, Michigan, United States
Newsom Eye and Laser Center
🇺🇸Sebring, Florida, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Argus Research at Cape Coral Eye Center
🇺🇸Cape Coral, Florida, United States
Eye Centers of Florida
🇺🇸Fort Myers, Florida, United States
Comprehensive Eye Care
🇺🇸Washington, Missouri, United States
Barnet Dulaney Perkins Eye Center
🇺🇸Phoenix, Arizona, United States