TearLab Refractive Surgery Dry Eye Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176045
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : February 4, 2016
TLC Laser Eye Center
Abbott Medical Optics
Information provided by (Responsible Party):
TearLab Corporation

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.

Condition or disease
Dry Eye Syndromes

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.

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Pre-surgical treatment
Patients who are pre & post-surgical treated with ocular lubricants.
Non-presurgical treatment
Patients who are only post-surgical treated with ocular lubricants

Primary Outcome Measures :
  1. Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery [ Time Frame: 6 months post surgery ]

Secondary Outcome Measures :
  1. To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively [ Time Frame: 6 months post-surgical ]
  2. To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery [ Time Frame: 6 months post-surgical ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176045

United States, Connecticut
Connecticut TLC
Fairfield, Connecticut, United States, 06824
United States, Illinois
Westchester TLC
Westchester, Illinois, United States, 60154
United States, Oklahoma
Oklahoma City TLC
Oklahoma City, Oklahoma, United States, 73116
Tulsa TLC
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Kremer Eye Center
King of Prussia, Pennsylvania, United States, 16406
United States, Texas
San Antonio TLC
San Antonio, Texas, United States, 78232
United States, Utah
Salt Lake City TLC
Salt Lake City, Utah, United States, 84121
United States, Virginia
Reston TLC
Reston, Virginia, United States, 20191
Sponsors and Collaborators
TearLab Corporation
TLC Laser Eye Center
Abbott Medical Optics
Study Director: James Owen, OD TLC The Laser Eye Center

Responsible Party: TearLab Corporation Identifier: NCT01176045     History of Changes
Other Study ID Numbers: TP00087
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data has been shared in Vienna 2011. Patients with pre-operative hyperosmolarity (≥ 308 mOsms/L) demonstrated worse long-term uncorrected visual acuity. An abnormal tear film may cause inaccurate wavefront aberrometry. For patients with preoperative osmolarity ≥ 308 mOsms/L, it may be important to continue therapy for at least 3 months. Similarly, surgeons should measure tear osmolarity preoperatively as staining was too insensitive to identify at-risk patients. Patients treated pre-operatively with AMO Blink® Tears achieved normal osmolarity faster than those untreated before surgery.

Keywords provided by TearLab Corporation:
Dry Eye Disease
Refractive Surgery

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases