NCT03240458

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 . .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

August 7, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 13, 2017

Last Update Submit

August 2, 2017

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • The prevalence of diabetic macular edema in diabetic patients

    The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .

    5 minutes

Interventions

Optical Coherence TomographyDEVICE

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

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

    PMID: 22913868BACKGROUND

  • 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.

    PMID: 7831044BACKGROUND

  • 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.

    PMID: 19068374BACKGROUND

  • 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.

    PMID: 15111519BACKGROUND

  • 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.

    PMID: 25816765BACKGROUND

  • 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.

    PMID: 24852439BACKGROUND

  • 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.

    PMID: 25935789BACKGROUND

  • 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.

    PMID: 25125075BACKGROUND

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Mohammed A Sayed, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Gamal N Mahmoud, professor

CONTACT

02201223211939gamalnouby@live.com

Mohammed S Abd-el Rahman, professor

CONTACT

0221222414233mohamed66saad@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investgator

Study Record Dates

First Submitted

July 13, 2017

First Posted

August 7, 2017

Study Start

August 10, 2017

Primary Completion

January 31, 2018

Study Completion

February 28, 2018

Last Updated

August 7, 2017

Record last verified: 2017-07