Back to resultsDispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Viscoat
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility 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
Sites / Locations
- Florida Eye Microsurgical Institute
- Eye Physicians of Central Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Saline
Viscoat
Arm Description
One group will receive Saline to irrigate the wound
One group will receive Viscoat to close the surgical wound
Outcomes
Primary Outcome Measures
Ensure watertight, patient wound closure after clear corneal cataract incisions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01298973
Brief Title
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Official Title
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Experimental
Arm Description
One group will receive Saline to irrigate the wound
Arm Title
Viscoat
Arm Type
Experimental
Arm Description
One group will receive Viscoat to close the surgical wound
Intervention Type
Drug
Intervention Name(s)
Viscoat
Intervention Description
One group will receive Viscoat for incision closure
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
One group will receive Saline to irrigate the wound
Primary Outcome Measure Information:
Title
Ensure watertight, patient wound closure after clear corneal cataract incisions
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Eye Physicians of Central Florida
City
Maitland
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
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