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

This study has been completed.
Information provided by:
Innovative Medical Identifier:
First received: January 28, 2011
Last updated: January 13, 2012
Last verified: January 2012
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.

Condition Intervention Phase
Drug: Viscoat
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions

Resource links provided by NLM:

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Ensure watertight, patient wound closure after clear corneal cataract incisions [ Time Frame: 1 year ]

Estimated Enrollment: 50
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saline
One group will receive Saline to irrigate the wound
Drug: Saline
One group will receive Saline to irrigate the wound
Experimental: Viscoat
One group will receive Viscoat to close the surgical wound
Drug: Viscoat
One group will receive Viscoat for incision closure


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01298973

United States, Florida
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Eye Physicians of Central Florida
Maitland, Florida, United States
Sponsors and Collaborators
Innovative Medical
  More Information

Responsible Party: Annie Christensen, CRO Identifier: NCT01298973     History of Changes
Other Study ID Numbers: Alcon2011-VIS-001
Study First Received: January 28, 2011
Last Updated: January 13, 2012

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on May 22, 2017