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The Pathogenesis of Idiopathic Dry Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
ClinicalTrials.gov Identifier:
NCT01254201
First received: December 3, 2010
Last updated: March 13, 2017
Last verified: March 2017
  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
Dry Eye Fibromyalgia

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Pathogenesis of Idiopathic Dry Eyes

Resource links provided by NLM:


Further study details as provided by Roni Shtein, University of Michigan:

Enrollment: 90
Study Start Date: June 2008
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dry Eye
Female patients over the age of 18 years with ocular complaints of dryness, grittiness, irritation, or related symptoms, without any identifiable cause.
Fibromyalgia
Female patients over the age of 18 years diagnosed with Fibromyalgia.
Healthy Control
Female patients over the age of 18 years with no symptoms of dry eyes and with no known diagnosis of Fibromyalgia.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Females aged 18 yrs or older in the community or seen in Kellogg Eye Center will be offered enrollment into the study.
Criteria

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
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: NCT01254201

Locations
United States, Michigan
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roni Shtein, MD University of Michigan
  More Information

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: March 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibromyalgia
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on August 18, 2017