EYEFILL® C. -US Viscoelastic Clinical Investigation
Completed · Not applicable
Conditions studied: Cataract
In brief
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.
Key facts
- Study ID
- NCT02024711
- Run by
- Bausch Health Americas, Inc.
- People needed
- 262
- Starts
- 2013-12-01
- Expected to finish
- 2014-12-17
- Last updated by the study team
- 2020-09-04
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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