Study Results
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View full resultsBasic Information
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COMPLETED
NA
262 participants
INTERVENTIONAL
2013-12-31
2014-12-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald R Sanders, MD, PhD
Role: STUDY_DIRECTOR
Center for Clinical Research
Locations
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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
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
Countries
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Other Identifiers
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EYE-C-7.00
Identifier Type: -
Identifier Source: org_study_id
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