Overview

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

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
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