The Pathogenesis of Idiopathic Dry Eyes
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Purpose
Dry eyes are a very common complaint. In some patients, we can identify the reason for the dryness; however, in others the dryness has no clear cause. Dryness can lead to eye irritation, redness, and sometimes changes in vision. Fibromyalgia is a condition of chronic pain that is poorly understood but seems to have a component of altered sensory processing. People with fibromyalgia tend to complain of dry and irritated eyes at a higher rate than the general population. We plan to evaluate patients with dry eye symptoms for abnormalities in sensory processing and in their autonomic nervous system. We hope to learn about possible relationships between dry eye symptoms and fibromyalgia in order to better understand and treat these conditions.
| Condition |
|---|
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Dry Eye Fibromyalgia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Dry Eye
Female patients over the age of 18 years with ocular complaints of dryness, grittiness, irritation, or related symptoms, without any identifiable cause.
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Fibromyalgia
Female patients over the age of 18 years diagnosed with Fibromyalgia.
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Healthy Control
Female patients over the age of 18 years with no symptoms of dry eyes and with no known diagnosis of Fibromyalgia.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Females aged 18 yrs or older in the community or seen in Kellogg Eye Center will be offered enrollment into the study.
Inclusion Criteria:
Healthy Controls:
Female over the age of 18, No symptoms of dry eyes, Must be able to read text on the computer screen and understand English, and not have a physical impairment that prevents you from completing a paper and pencil questionnaire or using a tablet computer
Fibromyalgia:
Female over the age of 18, No symptoms of dry eyes, Been diagnosed with fibromyalgia, Must be able to read text on the computer screen and understand English, and not have a physical impairment that prevents you from completing a paper and pencil questionnaire or using a tablet computer
Dry Eye:
Female over the age of 18, have symptoms of dry eyes, Must be able to read text on the computer screen and understand English, and not have a physical impairment that prevents you from completing a paper and pencil questionnaire or using a tablet computer
Exclusion Criteria:
Pregnant or breast feeding, use of medicated eye drops in last month (Artificial tears ok), diagnosis of autoimmune or rheumatologic disease (e.g. rheumatoid arthritis, crohn's disease, lupus, multiple sclerosis, etc), heart condition requiring daily medications (e.g. angina, congestive heart failure), COPD or asthma requiring daily inhalers (rescue inhalers ok), history of cancer in the past 2 years (skin cancer is ok), use of oral antihistamine medications (e.g. benadryl, claritin, clarinex, zyrtec, allegra, etc), use of oral anticholinergic medications (e.g. scopolamine, ditropan, detrol, ipratropium, etc)
Contacts and Locations| Contact: Munira Hussain, MS | 734-647-8397 | hussain@med.umich.edu |
| United States, Michigan | |
| University of Michigan Kellogg Eye Center | Recruiting |
| Ann Arbor, Michigan, United States, 48105 | |
| Contact: Munira Hussain, MS 734-647-8397 hussain@umich.edu | |
| Principal Investigator: | Roni Shtein, MD | University of Michigan |
More Information
No publications provided
| Responsible Party: | Roni Shtein, Assistant Professor of Ophthalmology and Visual Sciences, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01254201 History of Changes |
| Other Study ID Numbers: | HUM00013091 |
| Study First Received: | December 3, 2010 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Fibromyalgia Myofascial Pain Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases |
Keratitis Corneal Diseases Lacrimal Apparatus Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013