TearLab Refractive Surgery Dry Eye Study

Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01176045

Enrollment

128

Registered

2010-08-05

Start date

2010-06-30

Completion date

2011-12-31

Last updated

2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Disease, Osmolarity, Refractive Surgery, Lasik, TearLab

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery	6 months post surgery

Secondary

Measure	Time frame
To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively	6 months post-surgical
To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery	6 months post-surgical

Countries

United States

Outcome results