EYEFILL® C. -US Viscoelastic Clinical Investigation

Study 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.

Official Title
-----------------
EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: EYEFILL® C.-US Viscoelastic
* Device: Healon® Viscoelastic (CONTROL)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYEFILL® C.-US Viscoelastic<br>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<br>* 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.<br>|
| Active Comparator: Healon® Viscoelastic (CONTROL)<br>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)<br>* 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.<br>|

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Intraocular Lens, IOL, Aphakia