Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Terminated

• Conditions: Dry Eyes

• Registration Number: NCT01450787
• Lead Sponsor: COA Research Foundation, INC

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.

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 Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-03-09
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Results First Posted: 2013-09-30
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conjunctival Staining Score	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

Name	Time	Method
Tear Film Osmolarity	at the time of the exam	The tear film osmolarity is measured at the time of the exam.

Trial Locations

Locations (1)

Columbus Ophthalmalogy Associates; 🇺🇸 Columbus, Ohio, United States