Clinical trial NCT01176045: TearLab Refractive Surgery Dry Eye Study
Official title: Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Osmolarity
Refractive Surgery
Lasik
TearLab
Lead sponsor: TearLab Corporation
Sponsor class: INDUSTRY
Collaborators: name: TLC Laser Eye Center
name: Abbott Medical Optics
First posted: 2010-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.

Brief summary: The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.

Detailed description: Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.

Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.

Eligibility criteria: Inclusion Criteria:

* Male or female, twenty-one years of age or older.
* Confirmed diagnosis of refractive error receiving LASIK surgery.
* Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.

Exclusion Criteria:

* Compromised cognitive ability that may be expected to interfere with study compliance.
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
* Active ocular allergy
* Patients requiring punctual occlusion prior to surgery
* Patients requiring cyclosporine ophthalmic emulsion prior to surgery
* Standard exclusion criteria for refractive surgery used by each surgeon.
* Known hypersensitivity to any of the agents used in testing
* Ophthalmologic drop use within 2 hours of any visit

Primary outcomes:
measure: Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery
timeFrame: 6 months post surgery
Secondary outcomes:
measure: To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively
timeFrame: 6 months post-surgical
measure: To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery
timeFrame: 6 months post-surgical
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Connecticut TLC
state: Connecticut
city: Westchester
country: United States
facility: Westchester TLC
state: Illinois
city: Oklahoma City
country: United States
facility: Oklahoma City TLC
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa TLC
state: Oklahoma
city: King of Prussia
country: United States
facility: Kremer Eye Center
state: Pennsylvania
city: San Antonio
country: United States
facility: San Antonio TLC
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake City TLC
state: Utah
city: Reston
country: United States
facility: Reston TLC
state: Virginia
Study officials:
affiliation: TLC The Laser Eye Center
name: James Owen, OD
role: STUDY_DIRECTOR
References: