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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: Saline; Drug: Viscoat

• Registration Number: NCT01298973
• Lead Sponsor: Innovative Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	One group will receive Saline to irrigate the wound
Viscoat	Viscoat	One group will receive Viscoat to close the surgical wound

Primary Outcome Measures

Name	Time	Method
Ensure watertight, patient wound closure after clear corneal cataract incisions	1 year

Trial Locations

Locations (2)

Eye Physicians of Central Florida; 🇺🇸 Maitland, Florida, United States

Florida Eye Microsurgical Institute; 🇺🇸 Boynton Beach, Florida, United States