EYEFILL® C. -US Viscoelastic Clinical Investigation

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