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

August 2, 2017 updated by: Sara maksoud, Assiut University

Screening For Diabetic Macular Edema Among Diabetic Patients In Assiut University Hospital Using Optical Coherence Tomography

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 . .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

diabetic patients

Description

Inclusion Criteria:

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of diabetic macular edema in diabetic patients
Time Frame: 5 minutes
The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .
5 minutes

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Mohammed A Sayed, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

August 10, 2017

Primary Completion (Anticipated)

January 31, 2018

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMEDP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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