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Sponsors and Collaborators: |
Walter Reed Army Medical Center Schepens Eye Research Institute SUNY College of Optometry |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00411827 |
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.
Condition | Intervention |
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Keratoconjunctivitis Sicca |
Procedure: PRK with conjunctival impression cytology before and after surgery Procedure: LASIK with conjunctival impression cytology before and after surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK |
Estimated Enrollment: | 146 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
PRK
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Procedure: PRK with conjunctival impression cytology before and after surgery |
2: Active Comparator
LASIK
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Procedure: LASIK with conjunctival impression cytology before and after surgery
LASIK with conjunctival impression cytology before and after surgery
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Ages Eligible for Study: | 21 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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:
Contact: KRAIG BOWER, MD | 202.782.0202 | kraig.bower@na.amedd.army.mil |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Contact: Lamarr Peppers, BA 202-782-7862 lamarr.peppers@amedd.army.mil |
Principal Investigator: | KRAIG S BOWER, MD | WRAMC |
Study ID Numbers: | WRAMC WU#06-23014 |
Study First Received: | December 13, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00411827 History of Changes |
Health Authority: | United States: Federal Government |
Cytology Keratomileusis, Laser In Situ Keratectomy, Photorefractive, Excimer Laser |
Corneal Diseases Xerophthalmia Eye Diseases Lacrimal Apparatus Diseases Keratitis |
Dry Eye Syndromes Conjunctivitis Keratoconjunctivitis Conjunctival Diseases Keratoconjunctivitis Sicca |
Corneal Diseases Xerophthalmia Eye Diseases Lacrimal Apparatus Diseases Keratitis |
Dry Eye Syndromes Conjunctivitis Keratoconjunctivitis Conjunctival Diseases Keratoconjunctivitis Sicca |