Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

Completed

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT01049724

Run by

Fort Belvoir Community Hospital

People needed

196

Starts

2010-01-01

Expected to finish

2017-11-01

Last updated by the study team

2018-02-07

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Fort Belvoir Community Hospital — Fort Belvoir, Virginia, United States

Full record on ClinicalTrials.gov

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