EYEFILL® C. -US Viscoelastic Clinical Investigation



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:11/8/2014
Start Date:December 2013
Contact:Monica L Sanders, MS
Email:monica@drsmd.com
Phone:630-530-9700

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EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
9
sites
Kansas City, Missouri 64133
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Kansas City, MO
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Cape Coral, Florida 33904
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Cape Coral, FL
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Fort Myers, Florida 33901
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Fort Myers, FL
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Madison, Wisconsin 53715
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Madison, WI
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Phoenix, Arizona 85016
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Phoenix, AZ
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Redding, California
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Redding, CA
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Saint Joseph, Michigan 49085
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Saint Joseph, MI
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Sebring, Florida 33870
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Sebring, FL
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Washington, Missouri
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Washington, MO
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