Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK
|ClinicalTrials.gov Identifier: NCT00411827|
Recruitment Status : Unknown
Verified July 2014 by Samanta B. Rodgers, Fort Belvoir Community Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 15, 2006
Last Update Posted : July 17, 2014
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 or disease||Intervention/treatment|
|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 (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK|
|Study Start Date :||January 2008|
|Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||December 2014|
Active Comparator: 1
|Procedure: PRK with conjunctival impression cytology before and after surgery|
Active Comparator: 2
Procedure: LASIK with conjunctival impression cytology before and after surgery
LASIK with conjunctival impression cytology before and after surgery
- Dry eye [ Time Frame: one year after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411827
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Richard D Stutzman, MD||WRNMMC|