Clinical trial NCT02024711: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Intraocular Lens
IOL
Aphakia
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2013-12-31
Enrollment: 262
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Percent Cell Change (Preservation of Endothelium)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
timeFrame: 3 months
measure: Percentage of Participants With Anterior Chamber Inflammation
timeFrame: 3 months
measure: Percentage of Participants With Device-related Adverse Events Any Visit
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Redding
country: United States
facility: Shasta Eye Medical Group
state: California
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
city: Fort Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Sebring
country: United States
facility: Newsom Eye and Laser Center
state: Florida
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care
state: Missouri
Study officials:
affiliation: Center for Clinical Research
name: Donald R Sanders, MD, PhD
role: STUDY_DIRECTOR
References: