Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 15, 2006
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 20, 2024
September 1, 2024
3.1 years
December 13, 2006
September 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dry eye
one year after surgery
Study Arms (2)
1
ACTIVE COMPARATORPRK
2
ACTIVE COMPARATORLASIK
Interventions
LASIK with conjunctival impression cytology before and after surgery
Eligibility Criteria
You may qualify if:
- Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.
- Male or female, of any race, and at least 21 years old and not older than 40 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability and is the minimal age required by the FDA for informed consent for LASIK surgery.
- Manifest refractive spherical equivalent (MSE) of up to 10.00 diopters at the spectacle plane with refractive cylinder up to 3.00 D.
- Best spectacle corrected visual acuity of 20/20 or better in both eyes.
- Patients who are willing to fill out dry eye questionnaires.
- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12- month period immediately preceding the baseline examination, as confirmed by clinical records.
- All patients must be willing to return to the WRAMC Center for Refractive Surgery for follow up visits on Day1, Day 3, Day 7, and 1, 3, 6, and 12 months after their surgery.
- Located in the greater Washington DC area for a 14-month period.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements.
You may not qualify if:
- Previous surgery or trauma to the study eye.
- Dry eye as reflected by Schirmer's test with anesthesia of 0, subjective complaints or symptoms of dry eye, findings during the slit lamp exam that would be consistent with dry eye (e.g. superficial punctuate keratitis).
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatriptan (Imitrex).
- Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
- Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
- Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- History of recurrent erosions or epithelial basement dystrophy.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Stutzman, MD
WRNMMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 15, 2006
Study Start
January 1, 2008
Primary Completion
February 1, 2011
Study Completion
May 1, 2016
Last Updated
September 20, 2024
Record last verified: 2024-09