N/A
N=262
EYEFILL® C. -US Viscoelastic Clinical Investigation
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02024711 ↗Enrolled (actual)
262
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcome: Primary: Mean Percent Cell Change (Preservation of Endothelium) — -10.05; -10.13 percent cell change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EYEFILL® C.-US Viscoelastic (Device); Healon® Viscoelastic (CONTROL) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Cell Change (Preservation of Endothelium) |
-10.05; -10.13 | — |
| SECONDARY Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit |
24; 20 | — |
| SECONDARY Percentage of Participants With Anterior Chamber Inflammation |
2; 4; 2; 3; 4; 3 | — |
| SECONDARY Percentage of Participants With Device-related Adverse Events Any Visit |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02024711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.