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

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

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Drug: Saline; Drug: Viscoat

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boynton Beach, Florida, United States
      • Florida Eye Microsurgical Institute
    • Maitland, Florida, United States
      • Eye Physicians of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Saline; One group will receive Saline to irrigate the wound	Drug: Saline; One group will receive Saline to irrigate the wound
EXPERIMENTAL: Viscoat; One group will receive Viscoat to close the surgical wound	Drug: Viscoat; One group will receive Viscoat for incision closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ensure watertight, patient wound closure after clear corneal cataract incisions	1 year

Collaborators and Investigators

• Sponsor: Innovative Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (ESTIMATE): February 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 13, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Alcon2011-VIS-001