Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

NCT01049724 | Completed DMC

• 1 other identifier: 351515
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Myopia; refractive surgery; LASIK; PRK; Lacritin; Heparanase

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is tear lacritin levels pre- and post-surgery.

  pre and standard visits up to 6 months post-surgery

Secondary Outcomes (1)

• The secondary outcome is tear heparanase levels pre- and post-surgery

  pre- and at standard visits up to 6 months post-surgery

Study Arms (2)

PRK

Those patients undergoing photorefractive keratectomy

Other: Tear collection

LASIK

Those undergoing Laser-assisted insitu keratomileusis

Other: Tear collection

Interventions

Tear collection OTHER

Tear collection

LASIK; PRK

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fort Belvoir Community Hospital: lead
• James Madison University: collaborator
• University of Virginia: collaborator

Study Sites (1)

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Kraig S. Bower, MD

  The Wilmer Eye Institute, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

US (1)