Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
Launched by FORT BELVOIR COMMUNITY HOSPITAL · Jan 13, 2010
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Active duty US Army Soldiers eligible for care at FBCH
- • Undergoing PRK or LASIK
- • Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- • Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
- • Ability and willingness to understand and provide informed consent to participate in this study.
- • Up to -10.00 diopters of myopia.
- • Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
- • Consent of the subject's command (active duty) to participate in the study.
- • Access to transportation to meet follow-up requirements.
- Exclusion Criteria:
- • Any reason to be excluded for PRK or LASIK
- • Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. \[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not\]
- • 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.
- • Anterior basement membrane dystrophy
- • History of recurrent epithelial erosion
- • Significant dry eye (symptomatic with Schirmer \<5mm at 5 minutes)
- • Other corneal epithelial disorder or healing abnormality
- • Individuals with any infectious or inflammatory ocular conditions (e.g. have "pink eye" or uveitis).
- • Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotropic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
About Fort Belvoir Community Hospital
Fort Belvoir Community Hospital is a leading healthcare institution dedicated to providing high-quality medical care to military personnel, their families, and eligible beneficiaries. As a clinical trial sponsor, the hospital actively engages in innovative research aimed at advancing medical knowledge and improving patient outcomes. With a commitment to excellence in patient-centered care, Fort Belvoir Community Hospital collaborates with various stakeholders to facilitate clinical trials that align with its mission of enhancing health and wellness within the military community. The hospital's multidisciplinary team of healthcare professionals ensures rigorous adherence to ethical standards and regulatory requirements throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fort Belvoir, Virginia, United States
Patients applied
Trial Officials
Kraig S. Bower, MD
Principal Investigator
The Wilmer Eye Institute, Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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