Safety of Overnight Corneal Reshaping Lenses
Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT01272271
Collaborator
Bausch & Lomb Incorporated (Industry), Paragon Vision Sciences (Industry)
1,317
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Study Details
Study Description
Brief Summary
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.
Study Design
Study Type:
Observational
Actual Enrollment
:
1317 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children
|
|
| Adults
|
Outcome Measures
Primary Outcome Measures
- Microbial keratitis incidence [1 year]
Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Patients completing at least 3 months of wearing corneal reshaping lenses
Exclusion Criteria:
- Less than 3 months of wearing corneal reshaping lenses
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ohio State University
- Bausch & Lomb Incorporated
- Paragon Vision Sciences
Investigators
- Principal Investigator: Mark A Bullimore, PhD, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01272271
Other Study ID Numbers:
- 2007H0273
First Posted:
Jan 7, 2011
Last Update Posted:
Jan 7, 2011
Last Verified:
Jan 1, 2011