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OpenTrials
Completed

NCT Number: NCT00972621

Clinical Evaluation of a New Viscoelastic for Cataract Surgery

The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMO Clinical Research Call Center for Trial Locations

Santa Ana, California, 92799, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Otherwise healthy eye with no pathology other than the presence of cataract
  • Visual potential of 20/40 or better

Exclusion criteria

  • Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
  • Known intraocular pressure increases from steroid treatment
  • Low endothelial cell count

Treatment and study plan

Vitrax II

Device

Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.

Viscoat

Device

Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

Primary outcomes

  1. Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively

    Time frame: 3 months postoperative

    Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.

Secondary outcomes

  1. Postoperative Mean Endothelial Cell Count

    Time frame: 3 months postoperative

    mean endothelial cell count (measured by Konan specular microscope) at 3 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2009
Registry last updated
Feb 11, 2025

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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