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| Name | Class |
|---|---|
| TLC Laser Eye Center | UNKNOWN |
| Abbott Medical Optics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery | 6 months post surgery |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.
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| Name | Affiliation | Role |
|---|---|---|
| James Owen, OD | TLC The Laser Eye Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut TLC | Fairfield | Connecticut | 06824 | United States | ||
| Westchester TLC |
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.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 6 months post-surgical |
| Westchester |
| Illinois |
| 60154 |
| United States |
| Oklahoma City TLC | Oklahoma City | Oklahoma | 73116 | United States |
| Tulsa TLC | Tulsa | Oklahoma | 74133 | United States |
| Kremer Eye Center | King of Prussia | Pennsylvania | 16406 | United States |
| San Antonio TLC | San Antonio | Texas | 78232 | United States |
| Salt Lake City TLC | Salt Lake City | Utah | 84121 | United States |
| Reston TLC | Reston | Virginia | 20191 | United States |