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

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT01298973
Collaborator
(none)
50
2
2
12
25
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ensure watertight, patient wound closure after clear corneal cataract incisions [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida Eye Microsurgical Institute Boynton Beach Florida United States
2 Eye Physicians of Central Florida Maitland Florida United States

Sponsors and Collaborators

  • Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01298973
Other Study ID Numbers:
  • Alcon2011-VIS-001
First Posted:
Feb 18, 2011
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2012