TearLab Refractive Surgery Dry Eye Study

This study has been completed.
Sponsor:
Collaborators:
TLC Laser Eye Center
Abbott Medical Optics
Information provided by (Responsible Party):
TearLab Corporation
ClinicalTrials.gov Identifier:
NCT01176045
First received: August 3, 2010
Last updated: February 2, 2016
Last verified: February 2016

August 3, 2010
February 2, 2016
June 2010
December 2011   (final data collection date for primary outcome measure)
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01176045 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery [ Time Frame: 6 months post-surgical ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TearLab Refractive Surgery Dry Eye Study
Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.
Dry Eye Syndromes
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01176045
TP00087
No
Yes
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.
TearLab Corporation
TearLab Corporation
  • TLC Laser Eye Center
  • Abbott Medical Optics
Study Director: James Owen, OD TLC The Laser Eye Center
TearLab Corporation
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP