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

NCT ID: NCT01298973

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saline

One group will receive Saline to irrigate the wound

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

One group will receive Saline to irrigate the wound

Viscoat

One group will receive Viscoat to close the surgical wound

Group Type EXPERIMENTAL

Viscoat

Intervention Type DRUG

One group will receive Viscoat for incision closure

Interventions

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Viscoat

One group will receive Viscoat for incision closure

Intervention Type DRUG

Saline

One group will receive Saline to irrigate the wound

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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CRO

Locations

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Florida Eye Microsurgical Institute

Boynton Beach, Florida, United States

Site Status

Eye Physicians of Central Florida

Maitland, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Alcon2011-VIS-001

Identifier Type: -

Identifier Source: org_study_id

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