Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
1 other identifier
interventional
50
1 country
2
Brief Summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2011
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 18, 2012
January 1, 2012
1 year
January 28, 2011
January 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Ensure watertight, patient wound closure after clear corneal cataract incisions
1 year
Study Arms (2)
Saline
EXPERIMENTALOne group will receive Saline to irrigate the wound
Viscoat
EXPERIMENTALOne group will receive Viscoat to close the surgical wound
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Eye Physicians of Central Florida
Maitland, Florida, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 18, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 18, 2012
Record last verified: 2012-01