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EYEFILL® C. -US Viscoelastic Clinical Investigation

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EYEFILL® C.-US Viscoelastic
Healon® Viscoelastic (CONTROL)
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Intraocular Lens, IOL, Aphakia

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnet Dulaney Perkins Eye Center
  • Shasta Eye Medical Group
  • Argus Research at Cape Coral Eye Center
  • Eye Centers of Florida
  • Newsom Eye and Laser Center
  • Great Lakes Eye Care
  • Silverstein Eye Centers
  • Comprehensive Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EYEFILL® C.-US Viscoelastic

Healon® Viscoelastic (CONTROL)

Arm Description

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® 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.

Outcomes

Primary Outcome Measures

Mean Percent Cell Change (Preservation of Endothelium)
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.

Secondary Outcome Measures

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

Full Information

First Posted
December 27, 2013
Last Updated
September 2, 2020
Sponsor
Bausch Health Americas, Inc.
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02024711
Brief Title
EYEFILL® C. -US Viscoelastic Clinical Investigation
Official Title
EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 17, 2014 (Actual)
Study Completion Date
December 17, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Intraocular Lens, IOL, Aphakia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EYEFILL® C.-US Viscoelastic
Arm Type
Experimental
Arm Description
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.
Arm Title
Healon® Viscoelastic (CONTROL)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EYEFILL® C.-US Viscoelastic
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Healon® Viscoelastic (CONTROL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Percent Cell Change (Preservation of Endothelium)
Description
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Time Frame
3 months
Title
Percentage of Participants With Anterior Chamber Inflammation
Time Frame
3 months
Title
Percentage of Participants With Device-related Adverse Events Any Visit
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald R Sanders, MD, PhD
Organizational Affiliation
Center for Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Shasta Eye Medical Group
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
Argus Research at Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Eye Centers of Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Newsom Eye and Laser Center
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Facility Name
Great Lakes Eye Care
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Comprehensive Eye Care
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States

12. IPD Sharing Statement

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EYEFILL® C. -US Viscoelastic Clinical Investigation

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