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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298973
• Other study ID #: Alcon2011-VIS-001
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2011
• Last updated: January 13, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Drug:
• Viscoat
One group will receive Viscoat for incision closure
• Saline
One group will receive Saline to irrigate the wound

Locations

Country	Name	City	State
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Eye Physicians of Central Florida	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ensure watertight, patient wound closure after clear corneal cataract incisions		1 year	No