EYEFILL® C. -US Viscoelastic Clinical Investigation

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT02024711
• Lead Sponsor: Bausch Health Americas, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Primary Completion: 2014-12-17
• Study Completion: 2014-12-17
• Disposition First Submitted: 2019-10-16
• Disposition First Submitted QC: 2019-10-16
• Disposition First Posted: 2019-10-24
• Results First Submitted: 2020-08-18
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Percent Cell Change (Preservation of Endothelium)	Baseline, 3 months	Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Anterior Chamber Inflammation	3 months
Percentage of Participants With Device-related Adverse Events Any Visit	3 months
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit	3 months

Trial Locations

Locations (8)

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