Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
NCT ID: NCT01298973
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Saline
One group will receive Saline to irrigate the wound
Saline
One group will receive Saline to irrigate the wound
Viscoat
One group will receive Viscoat to close the surgical wound
Viscoat
One group will receive Viscoat for incision closure
Interventions
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Viscoat
One group will receive Viscoat for incision closure
Saline
One group will receive Saline to irrigate the wound
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Innovative Medical
INDUSTRY
Responsible Party
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CRO
Locations
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Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Eye Physicians of Central Florida
Maitland, Florida, United States
Countries
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Other Identifiers
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Alcon2011-VIS-001
Identifier Type: -
Identifier Source: org_study_id
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