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Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00432874
First received: February 6, 2007
Last updated: October 15, 2010
Last verified: October 2010
History of Changes
  Purpose

The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.


Condition Intervention
Cataract
 Procedure: wound hydration method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Proportion of eyes with wound leakage at the end of surgery [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Anterior stromal hydration ("Wong" method)
 Procedure: wound hydration method
Anterior vs lateral wound hydration
Active Comparator: 2
Traditional lateral wound hydration
 Procedure: wound hydration method
Anterior vs lateral wound hydration

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Visually significant cataract requiring surgery

Exclusion Criteria:

  • Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
  • Any intraoperative complications
  • Cataract incision length < 1 mm
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432874

Locations
United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark D Mifflin, MD University of Utah
  More Information

No publications provided

Responsible Party: Dr. Mark Mifflin, University of Utah
ClinicalTrials.gov Identifier: NCT00432874     History of Changes
Other Study ID Numbers: UT16122
Study First Received: February 6, 2007
Last Updated: October 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013