EYEFILL® C. -US Viscoelastic Clinical Investigation

Cataract Clinical Trial

Official title:

EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024711
• Other study ID #: EYE-C-7.00
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 17, 2014

Study information

• Verified date: September 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 17, 2014
• Est. primary completion date: December 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• EYEFILL® C.-US Viscoelastic
EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
• Healon® Viscoelastic (CONTROL)
Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.

Locations

Country	Name	City	State
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Eye Centers of Florida	Fort Myers	Florida
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona
United States	Shasta Eye Medical Group	Redding	California
United States	Great Lakes Eye Care	Saint Joseph	Michigan
United States	Newsom Eye and Laser Center	Sebring	Florida
United States	Comprehensive Eye Care	Washington	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Cell Change (Preservation of Endothelium)	Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.	Baseline, 3 months
Secondary	Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit		3 months
Secondary	Percentage of Participants With Anterior Chamber Inflammation		3 months
Secondary	Percentage of Participants With Device-related Adverse Events Any Visit		3 months