Overview
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Status:
Completed
Completed
Trial end date:
2012-01-01
2012-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Innovative Medical
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