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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03240458
• Other study ID #: DMEDP
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2017
• Last updated: August 2, 2017
• Start date: August 10, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: Gamal N Mahmoud, professor
• Phone: 02201223211939
• Email: gamalnouby[@]live.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 . .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Device:
• Optical Coherence Tomography
an objective non-invasive method for high-resolution cross-sectional imaging of the retina

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Romero-Aroca P, Reyes-Torres J, Baget-Bernaldiz M, Blasco-Suñe C. Laser treatment for diabetic macular edema in the 21st century. Curr Diabetes Rev. 2014 Mar;10(2):100-12. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of diabetic macular edema in diabetic patients	The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .	5 minutes