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

October 15, 2010 updated by: University of Utah

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • John Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of eyes with wound leakage at the end of surgery
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Mark D Mifflin, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 7, 2007

First Posted (Estimate)

February 8, 2007

Study Record Updates

Last Update Posted (Estimate)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 15, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UT16122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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