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 ]

Specular Microscope Photographs


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