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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.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01298973
First received: January 28, 2011
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cataracts
 Drug: Viscoat
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298973

Locations
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

No publications provided

Responsible Party: Annie Christensen, CRO
ClinicalTrials.gov Identifier: NCT01298973     History of Changes
Other Study ID Numbers: Alcon2011-VIS-001
Study First Received: January 28, 2011
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013