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

NCT ID: NCT03240458

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-02-28

Brief Summary

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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

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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 .

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Optical Coherence Tomography

an objective non-invasive method for high-resolution cross-sectional imaging of the retina

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sara maksoud

principle investgator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A Sayed, Lecturer

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Gamal N Mahmoud, professor

Role: CONTACT

02201223211939

Mohammed S Abd-el Rahman, professor

Role: CONTACT

0221222414233

References

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Studnicka J. [The diabetic macular edema--new possibilities of the treatment]. Cesk Slov Oftalmol. 2012 May;68(2):61-3. Czech.

Reference Type BACKGROUND
PMID: 22913868 (View on PubMed)

Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995 Jan;102(1):7-16. doi: 10.1016/s0161-6420(95)31052-4.

Reference Type BACKGROUND
PMID: 7831044 (View on PubMed)

Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XXII the twenty-five-year progression of retinopathy in persons with type 1 diabetes. Ophthalmology. 2008 Nov;115(11):1859-68. doi: 10.1016/j.ophtha.2008.08.023.

Reference Type BACKGROUND
PMID: 19068374 (View on PubMed)

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

Reference Type BACKGROUND
PMID: 15111519 (View on PubMed)

Zhang J, Ma J, Zhou N, Zhang B, An J. Insulin use and risk of diabetic macular edema in diabetes mellitus: a systemic review and meta-analysis of observational studies. Med Sci Monit. 2015 Mar 30;21:929-36. doi: 10.12659/MSM.892056.

Reference Type BACKGROUND
PMID: 25816765 (View on PubMed)

Romero-Aroca P, Reyes-Torres J, Baget-Bernaldiz M, Blasco-Sune C. Laser treatment for diabetic macular edema in the 21st century. Curr Diabetes Rev. 2014 Mar;10(2):100-12. doi: 10.2174/1573399810666140402123026.

Reference Type BACKGROUND
PMID: 24852439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25935789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25125075 (View on PubMed)

Other Identifiers

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DMEDP

Identifier Type: -

Identifier Source: org_study_id

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