EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 262
- Locations
- 8
- Primary Endpoint
- Mean Percent Cell Change (Preservation of Endothelium)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Mean Percent Cell Change (Preservation of Endothelium)
Time Frame: Baseline, 3 months
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Secondary Outcomes
- 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)