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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: EYEFILL® C.-US Viscoelastic; Device: Healon® Viscoelastic (CONTROL)

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Barnet Dulaney Perkins Eye Center
  • California
    • Redding, California, United States, 96002
      • Shasta Eye Medical Group
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research at Cape Coral Eye Center
    • Fort Myers, Florida, United States, 33901
      • Eye Centers of Florida
    • Sebring, Florida, United States, 33870
      • Newsom Eye and Laser Center
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Collaborators: Bausch & Lomb Incorporated
• Investigators: Study Director: Donald R Sanders, MD, PhD, Center for Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 17, 2014
• Study Completion (Actual): December 17, 2014

Study Registration Dates

• First Submitted: December 27, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cataract; IOL; Intraocular Lens; Aphakia
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: EYE-C-7.00