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Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fort Belvoir Community Hospital
Sponsor:
Collaborators:
James Madison University
University of Virginia
Rappaport Faculty of Medicine Cancer and Vascular Biology Research Center
Information provided by (Responsible Party):
LTC Bruce Rivers, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier:
NCT01049724
First received: January 13, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Myopia
Other: Tear collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

Further study details as provided by Fort Belvoir Community Hospital:

Primary Outcome Measures:
  • The primary outcome measure is tear lacritin levels pre- and post-surgery. [ Time Frame: pre and standard visits up to 6 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is tear heparanase levels pre- and post-surgery [ Time Frame: pre- and at standard visits up to 6 months post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 196
Study Start Date: January 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PRK
Those patients undergoing photorefractive keratectomy
Other: Tear collection
Tear collection
LASIK
Those undergoing Laser-assisted insitu keratomileusis
Other: Tear collection
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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Active duty US Army Soldiers eligible for care at WRAMC
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049724

Contacts
Contact: Denise S Ryan, MS 571-231-1600 denise.sediq@us.army.mil
Contact: Rose K Sia, MD 571-231-1600 rose.sia@us.army.mil

Locations
United States, Virginia
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Lamarr Peppers    571-231-1600    lamarr.peppers1@us.army.mil   
Contact: Rose Sia, MD       rose.sia@us.army.mil   
Sponsors and Collaborators
Fort Belvoir Community Hospital
James Madison University
University of Virginia
Rappaport Faculty of Medicine Cancer and Vascular Biology Research Center
Investigators
Principal Investigator: Kraig S. Bower, MD The Wilmer Eye Institute, Johns Hopkins University
  More Information

No publications provided

Responsible Party: LTC Bruce Rivers, Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT01049724     History of Changes
Other Study ID Numbers: 351515
Study First Received: January 13, 2010
Last Updated: August 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Fort Belvoir Community Hospital:
Myopia
refractive surgery
LASIK
PRK
Lacritin
Heparanase

ClinicalTrials.gov processed this record on November 23, 2014