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Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

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ClinicalTrials.gov Identifier: NCT01450787
Recruitment Status : Terminated (Principle investigator changed practice location and discontinued study)
First Posted : October 12, 2011
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.

Condition or disease
Dry Eyes

Detailed Description:
Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Study Design

Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics
Study Start Date : January 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
diabetics
diabetics
non diabetics
non diabetics


Outcome Measures

Primary Outcome Measures :
  1. Conjunctival Staining Score [ Time Frame: at the time of the evaluation ]
    Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.


Secondary Outcome Measures :
  1. Tear Film Osmolarity [ Time Frame: at the time of the exam ]
    The tear film osmolarity is measured at the time of the exam.


Other Outcome Measures:
  1. OSDI Score [ Time Frame: at the time of the exam ]
    The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.

  2. Schirmer Score [ Time Frame: at the time of the exam ]
    The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.

  3. Tear Break-up Time [ Time Frame: at the time of the exam ]
    The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.

  4. Corneal Staining [ Time Frame: at the time of the exam ]
    Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Existing clinic population from our practice
Criteria

Inclusion Criteria:

  • 50 patients with diabetes, 25 without diabetes over the age of 40

Exclusion Criteria:

  • current use of glaucoma drops or currently within the postoperative period from eye surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450787


Locations
United States, Ohio
Columbus Ophthalmalogy Associates
Columbus, Ohio, United States, 43213
Sponsors and Collaborators
COA Research Foundation, INC
Allergan
Investigators
Principal Investigator: Kenneth A Beckman, MD COA Research Foundation
More Information

Responsible Party: COA Research Foundation, INC
ClinicalTrials.gov Identifier: NCT01450787     History of Changes
Other Study ID Numbers: 000322
First Posted: October 12, 2011    Key Record Dates
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013
Last Verified: August 2013

Keywords provided by COA Research Foundation, INC:
dry eyes
diabetes

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