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 |
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.
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
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