<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240458</url>
  </required_header>
  <id_info>
    <org_study_id>DMEDP</org_study_id>
    <nct_id>NCT03240458</nct_id>
  </id_info>
  <brief_title>Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography</brief_title>
  <official_title>Screening For Diabetic Macular Edema Among Diabetic Patients In Assiut University Hospital Using Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic macular edema is one of the major causes of visual impairment in diabetic&#xD;
      retinopathy patients especially in the working age group. The problem is likely to increase&#xD;
      in the future with statistics showing a growing number of the diabetic population especially&#xD;
      in the Middle East . .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The worldwide prevalence of diabetic macular edema was reported as 6.81% among patients with&#xD;
      diabetes. Other research reported that the 10-year incidence of diabetic macular edema was&#xD;
      14% in individuals with type 2 diabetes, and progression to diabetic macular edema occurred&#xD;
      in 29% of individuals with type 1 diabetes over 25 years if left untreated . Although&#xD;
      diabetic macular edema resolves spontaneously in about 33% to 35% of patients, it tends to be&#xD;
      chronic in most patients..Diabetic macular edema can occur at any stage of diabetic&#xD;
      retinopathy . The symptoms of diabetic macular range from slight visual blurring to complete&#xD;
      blindness if left untreated . Optical coherence tomography is an objective non-invasive&#xD;
      method for high-resolution cross-sectional imaging of the retina .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 10, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of diabetic macular edema in diabetic patients</measure>
    <time_frame>5 minutes</time_frame>
    <description>The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography</intervention_name>
    <description>an objective non-invasive method for high-resolution cross-sectional imaging of the retina</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        diabetic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type 1or type 2 Diabetes Mellitus.&#xD;
&#xD;
          -  Fundus examination and optical coherence tomography can be done with no significant&#xD;
             hazy media&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous ocular surgery (e.g. vitreo-retinal surgery, glaucoma surgery).&#xD;
&#xD;
          2. Presence of co-existing retinal or choroidal disease (e.g. high myopia, retinitis&#xD;
             pigmentosa and Age-related macular degeneration)&#xD;
&#xD;
          3. Other associated ocular conditions (ex. glaucoma &amp; corneal opacity &amp; iritis).&#xD;
&#xD;
          4. Previous history of trauma.&#xD;
&#xD;
          5. Pregnancy induced diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed A Sayed, Lecturer</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gamal N Mahmoud, professor</last_name>
    <phone>02201223211939</phone>
    <email>gamalnouby@live.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammed S Abd-el Rahman, professor</last_name>
    <phone>0221222414233</phone>
    <email>mohamed66saad@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Studnicka J. [The diabetic macular edema--new possibilities of the treatment]. Cesk Slov Oftalmol. 2012 May;68(2):61-3. Czech.</citation>
    <PMID>22913868</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/s0161-6420(95)31052-4.</citation>
    <PMID>7831044</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19068374</PMID>
  </reference>
  <reference>
    <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. doi: 10.2337/diacare.27.5.1047.</citation>
    <PMID>15111519</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25816765</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24852439</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25935789</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25125075</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sara maksoud</investigator_full_name>
    <investigator_title>principle investgator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240458
org study id: DMEDP
nct id: NCT03240458
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 . .
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 .
observational model: Other
time perspective: Prospective
measure: The prevalence of diabetic macular edema in diabetic patients
time frame: 5 minutes
description: The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .
intervention type: Device
intervention name: Optical Coherence Tomography
description: an objective non-invasive method for high-resolution cross-sectional imaging of the retina
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohammed A Sayed, Lecturer
role: Study Chair
affiliation: Assiut University
last name: Gamal N Mahmoud, professor
phone: 02201223211939
email: gamalnouby@live.com
last name: Mohammed S Abd-el Rahman, professor
phone: 0221222414233
email: mohamed66saad@gmail.com
citation: Studnicka J. [The diabetic macular edema--new possibilities of the treatment]. Cesk Slov Oftalmol. 2012 May;68(2):61-3. Czech.
PMID: 22913868
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. doi: 10.1016/s0161-6420(95)31052-4.
PMID: 7831044
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.
PMID: 19068374
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. doi: 10.2337/diacare.27.5.1047.
PMID: 15111519
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.
PMID: 25816765
citation: 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: 24852439
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.
PMID: 25935789
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.
PMID: 25125075
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sara maksoud
investigator title: principle investgator
mesh term: Macular Edema
mesh term: Edema