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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
  Purpose
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 Phase
Dry Eye Syndromes
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing

Resource links provided by NLM:


Further study details as provided by TearLab Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176045

Locations
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
Investigators
Study Director: James Owen, OD TLC The Laser Eye Center
  More Information

Responsible Party: TearLab Corporation
ClinicalTrials.gov Identifier: NCT01176045     History of Changes
Other Study ID Numbers: TP00087 
Study First Received: August 3, 2010
Last Updated: February 2, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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
Osmolarity
Refractive Surgery
Lasik
TearLab

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

ClinicalTrials.gov processed this record on September 26, 2016