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| Descriptive Information Fields | |||||
| 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 | ||||
| Primary Outcome Measure † | Dry eye [ Time Frame: one year after surgery ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Keratoconjunctivitis Sicca | ||||
| Intervention † | Procedure: conjunctival impression cytology | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 146 | ||||
| Start Date † | January 2008 | ||||
| Completion Date | December 2009 | ||||
| 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 | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00411827 | ||||
| Organization ID | WRAMC WU#06-23014 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Walter Reed Army Medical Center | ||||
| Collaborators †† | Schepens Eye Research Institute | ||||
| Investigators † |
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| Information Provided By | Walter Reed Army Medical Center | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | December 13, 2006 | ||||
| Last Updated Date | June 25, 2008 | ||||