Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049724
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : February 7, 2018
James Madison University
University of Virginia
Information provided by (Responsible Party):
COL Bruce Rivers, Fort Belvoir Community Hospital

Brief Summary:
The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.

Condition or disease Intervention/treatment
Myopia Other: Tear collection

Detailed Description:
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 HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.

Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
Study Start Date : January 2010
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
Those patients undergoing photorefractive keratectomy
Other: Tear collection
Tear collection

Those undergoing Laser-assisted insitu keratomileusis
Other: Tear collection
Tear collection

Primary Outcome Measures :
  1. The primary outcome measure is tear lacritin levels pre- and post-surgery. [ Time Frame: pre and standard visits up to 6 months post-surgery ]

Secondary Outcome Measures :
  1. The secondary outcome is tear heparanase levels pre- and post-surgery [ Time Frame: pre- and at standard visits up to 6 months post-surgery ]

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Active duty military aged 21 to 55 with myopia up to -10.00 diopters eligible for care at Walter Reed Army Medical Center.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049724

United States, Virginia
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
Sponsors and Collaborators
Fort Belvoir Community Hospital
James Madison University
University of Virginia
Principal Investigator: Kraig S. Bower, MD The Wilmer Eye Institute, Johns Hopkins University

Responsible Party: COL Bruce Rivers, Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital Identifier: NCT01049724     History of Changes
Other Study ID Numbers: 351515
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by COL Bruce Rivers, Fort Belvoir Community Hospital:
refractive surgery

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases