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Tracking Information | |||||
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First Received Date † | December 13, 2006 | ||||
Last Updated Date | November 26, 2008 | ||||
Start Date † | January 2008 | ||||
Current Primary Outcome Measures † |
Dry eye [ Time Frame: one year after surgery ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00411827 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK | ||||
Official Title † | Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK | ||||
Brief Summary | Purpose: To develop a screening metric by examining both the characteristics of the preoperative tear film and the intracellular signaling pathways of conjunctival goblet cells in order to determine if there are certain characteristics which might predict those patients who will experience serious dry eye symptoms and complications after refractive surgery. Research Design: This study is a twelve-month prospective non-randomized investigation. Methodology: In conjunction with psychometric questionnaires and various measures of tear film quality (e.g. Schirmer's test, tear break up time, etc), impression cytology will be used to assess the intracellular signaling pathways of conjunctival goblet cells and to determine if alterations in this pathway exist. Alterations in this pathway would result in a reduced response by the mucin secreting conjunctival goblet cells thereby promoting the development of dry eye after refractive surgery. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment | ||||
Condition † | Keratoconjunctivitis Sicca | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 146 | ||||
Estimated Completion Date | December 2009 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria: Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 40 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00411827 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Walter Reed Army Medical Center | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | Walter Reed Army Medical Center | ||||
Verification Date | November 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |