Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

This study has been terminated.
(Principle investigator changed practice location and discontinued study)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
COA Research Foundation, INC
ClinicalTrials.gov Identifier:
NCT01450787
First received: October 10, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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
Dry Eyes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Resource links provided by NLM:


Further study details as provided by COA Research Foundation, INC:

Primary Outcome Measures:
  • Conjunctival Staining Score [ Time Frame: at the time of the evaluation ] [ Designated as safety issue: No ]
    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:
  • Tear Film Osmolarity [ Time Frame: at the time of the exam ] [ Designated as safety issue: No ]
    The tear film osmolarity is measured at the time of the exam.


Other Outcome Measures:
  • OSDI Score [ Time Frame: at the time of the exam ] [ Designated as safety issue: No ]
    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.

  • Schirmer Score [ Time Frame: at the time of the exam ] [ Designated as safety issue: No ]
    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.

  • Tear Break-up Time [ Time Frame: at the time of the exam ] [ Designated as safety issue: No ]
    The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.

  • Corneal Staining [ Time Frame: at the time of the exam ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
diabetics
diabetics
non diabetics
non diabetics

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: COA Research Foundation, INC
ClinicalTrials.gov Identifier: NCT01450787     History of Changes
Other Study ID Numbers: 000322
Study First Received: October 10, 2011
Results First Received: March 9, 2013
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014