TearLab Refractive Surgery Dry Eye Study
This study has been completed.
Sponsor:
TearLab Corporation
Collaborators:
TLC Laser Eye Centers
Abbott Medical Optics
Information provided by (Responsible Party):
TearLab Corporation
ClinicalTrials.gov Identifier:
NCT01176045
First received: August 3, 2010
Last updated: December 14, 2011
Last verified: December 2011
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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.
| 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:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
MedlinePlus related topics:
Eye Diseases
U.S. FDA Resources
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
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| 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
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 Centers
Abbott Medical Optics
Investigators
| Study Director: | James Owen, OD | TLC The Laser Eye Center |
More Information
No publications provided
| Responsible Party: | TearLab Corporation |
| ClinicalTrials.gov Identifier: | NCT01176045 History of Changes |
| Other Study ID Numbers: | TP00087 |
| Study First Received: | August 3, 2010 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by TearLab Corporation:
|
Dry Eye Disease Osmolarity Refractive Surgery Lasik TearLab |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013