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Completed

NCT Number: NCT02024711

EYEFILL® C. -US Viscoelastic Clinical Investigation

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.

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Key information

Conditions

Cataract Aphakia Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnet Dulaney Perkins Eye Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EYEFILL® C.-US Viscoelastic

Device

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.

Healon® Viscoelastic (CONTROL)

Device

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.

Primary outcomes

  1. 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

  1. Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit

    Time frame: 3 months

  2. Percentage of Participants With Anterior Chamber Inflammation

    Time frame: 3 months

  3. Percentage of Participants With Device-related Adverse Events Any Visit

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2013
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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