Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration
A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration
1 other identifier
interventional
60
1 country
1
Brief Summary
The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 6, 2007
CompletedFirst Posted
Study publicly available on registry
February 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 19, 2010
October 1, 2010
1.8 years
February 6, 2007
October 15, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of eyes with wound leakage at the end of surgery
Intraoperative
Study Arms (2)
1
EXPERIMENTALAnterior stromal hydration ("Wong" method)
2
ACTIVE COMPARATORTraditional lateral wound hydration
Interventions
Eligibility Criteria
You may qualify if:
- Visually significant cataract requiring surgery
You may not qualify if:
- Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
- Any intraoperative complications
- Cataract incision length \< 1 mm
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Moran Eye Center
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Mifflin, MD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 6, 2007
First Posted
February 8, 2007
Study Start
February 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
October 19, 2010
Record last verified: 2010-10