Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography

• Conditions: Diabetic Macular Edema

• Registration Number: NCT03240458
• Lead Sponsor: Assiut University

Brief Summary

Diabetic macular edema is one of the major causes of visual impairment in diabetic retinopathy patients especially in the working age group. The problem is likely to increase in the future with statistics showing a growing number of the diabetic population especially in the Middle East . .

Detailed Description

The worldwide prevalence of diabetic macular edema was reported as 6.81% among patients with diabetes. Other research reported that the 10-year incidence of diabetic macular edema was 14% in individuals with type 2 diabetes, and progression to diabetic macular edema occurred in 29% of individuals with type 1 diabetes over 25 years if left untreated . Although diabetic macular edema resolves spontaneously in about 33% to 35% of patients, it tends to be chronic in most patients..Diabetic macular edema can occur at any stage of diabetic retinopathy . The symptoms of diabetic macular range from slight visual blurring to complete blindness if left untreated . Optical coherence tomography is an objective non-invasive method for high-resolution cross-sectional imaging of the retina .

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07
• Study Start: 2017-08-10
• Primary Completion: 2018-01-31
• Study Completion: 2018-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with type 1or type 2 Diabetes Mellitus.
• Fundus examination and optical coherence tomography can be done with no significant hazy media

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Exclusion Criteria

1. Previous ocular surgery (e.g. vitreo-retinal surgery, glaucoma surgery).
2. Presence of co-existing retinal or choroidal disease (e.g. high myopia, retinitis pigmentosa and Age-related macular degeneration)
3. Other associated ocular conditions (ex. glaucoma & corneal opacity & iritis).
4. Previous history of trauma.
5. Pregnancy induced diabetes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of diabetic macular edema in diabetic patients	5 minutes	The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .