Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Study Details
Study Description
Brief Summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
|
Outcome Measures
Primary Outcome Measures
- Ensure watertight, patient wound closure after clear corneal cataract incisions [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability to provide informed consent, complete questionnaires, and likely to complete all visits
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Subject must be male or female, of any race, and at least 21 years old
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Undergoing uncomplicated cataract surgery with clear corneal incisions
Exclusion Criteria:
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Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
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Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
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Uncontrolled systemic disease
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Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
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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
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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
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Concurrent participation or participation in the last 30 days in any other clinical trial
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Florida Eye Microsurgical Institute | Boynton Beach | Florida | United States | |
2 | Eye Physicians of Central Florida | Maitland | Florida | United States |
Sponsors and Collaborators
- Innovative Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Alcon2011-VIS-001