Clinical trial NCT03240458: Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography
Official title: Screening For Diabetic Macular Edema Among Diabetic Patients In Assiut University Hospital Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic patients

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 .

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of diabetic macular edema in diabetic patients
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammed A Sayed, Lecturer
role: STUDY_CHAIR
References:
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citation: Das A, McGuire PG, Rangasamy S. Diabetic Macular Edema: Pathophysiology and Novel Therapeutic Targets. Ophthalmology. 2015 Jul;122(7):1375-94. doi: 10.1016/j.ophtha.2015.03.024. Epub 2015 Apr 30.
citation: Varma R, Bressler NM, Doan QV, Gleeson M, Danese M, Bower JK, Selvin E, Dolan C, Fine J, Colman S, Turpcu A. Prevalence of and risk factors for diabetic macular edema in the United States. JAMA Ophthalmol. 2014 Nov;132(11):1334-40. doi: 10.1001/jamaophthalmol.2014.2854.