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 |
---|---|---|
|
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
- 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: