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

Innovative Medical

Status and phase

Completed

Phase 4

Conditions

Cataracts

Treatments

Drug: Saline

Drug: Viscoat

Study type

Interventional

Funder types

Industry

Identifiers

Alcon2011-VIS-001

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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