Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

August 8, 2013 updated by: COA Research Foundation, INC
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Columbus Ophthalmalogy Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Existing clinic population from our practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
diabetics
non diabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the time of the evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Film Osmolarity
Time Frame: at the time of the exam
The tear film osmolarity is measured at the time of the exam.
at the time of the exam

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the time of the exam
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.
at the time of the exam
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.
at the time of the exam
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.
at the time of the exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COA Research Foundation, INC

Collaborators

Allergan

Investigators

  • Principal Investigator: Kenneth A Beckman, MD, COA Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eyes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe