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OpenTrials
Completed

NCT Number: NCT01298973

Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions

The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.

Completed

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Florida Eye Microsurgical Institute, Boynton Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to provide informed consent, complete questionnaires, and likely to complete all visits
  • Subject must be male or female, of any race, and at least 21 years old
  • Undergoing uncomplicated cataract surgery with clear corneal incisions

Exclusion criteria

  • Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
  • Uncontrolled systemic disease
  • Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
  • Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
  • Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
  • Concurrent participation or participation in the last 30 days in any other clinical trial

Treatment and study plan

Viscoat

Drug

One group will receive Viscoat for incision closure

Saline

Drug

One group will receive Saline to irrigate the wound

Primary outcomes

  1. Ensure watertight, patient wound closure after clear corneal cataract incisions

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2011
Registry last updated
Jan 18, 2012

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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