EYEFILL® C. -US Viscoelastic Clinical Investigation

Bausch Health

Status: Completed

Conditions: Cataract

Treatments: Device: EYEFILL® C.-US Viscoelastic; Device: Healon® Viscoelastic (CONTROL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02024711

EYE-C-7.00

Details and patient eligibility

About

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.

Enrollment: 262 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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262 participants in 2 patient groups

EYEFILL® C.-US Viscoelastic

Experimental group

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.

Treatment:

Device: EYEFILL® C.-US Viscoelastic

Healon® Viscoelastic (CONTROL)

Active Comparator group

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.

Treatment:

Device: Healon® Viscoelastic (CONTROL)