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

This study has been completed.
Information provided by:
University of Utah Identifier:
First received: February 6, 2007
Last updated: October 15, 2010
Last verified: October 2010
The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.

Condition Intervention
Procedure: wound hydration method

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

Resource links provided by NLM:

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 ]

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00432874

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

Responsible Party: Dr. Mark Mifflin, University of Utah Identifier: NCT00432874     History of Changes
Other Study ID Numbers: UT16122
Study First Received: February 6, 2007
Last Updated: October 15, 2010

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on April 28, 2017