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

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT00432874
Collaborator
(none)
60
1
2
34
1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: wound hydration method
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Official Title:
A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of eyes with wound leakage at the end of surgery [Intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00432874
Other Study ID Numbers:
  • UT16122
First Posted:
Feb 8, 2007
Last Update Posted:
Oct 19, 2010
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2010