Clinical Trial: EYEFILL® C. -US Viscoelastic Clinical Investigation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
Brief Summary:
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.
Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.
Current Primary Outcome: Preservation of Endothelium [ Time Frame: 3 months ]
Original Primary Outcome:
Current Secondary Outcome:
- Incidence of IOP spikes >/= 30 mmHg at all postoperative follow-up visits [ Time Frame: 3 months ]Tonometry
- Cumulative rate and severity of inflammatory response at all postoperative follow-up visits [ Time Frame: 3 months ]Anterior Chamber Flare and Cell Assessments
- Cumulative rate and severity of other device-related adverse events at all postoperative follow-up visits [ Time Frame: 3 months ]Clinical Assessment
Original Secondary Outcome:
Information By: Valeant Pharmaceuticals International, Inc.
Dates:
Date Received: December 27, 2013
Date Started: December 2013
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015