Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-05 @ 1:09 AM
Study NCT ID:
NCT03240458
Status:
UNKNOWN
Last Update Posted:
2017-08-07
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of diabetic macular edema in diabetic patients', 'timeFrame': '5 minutes', 'description': 'The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '22913868', 'type': 'BACKGROUND', 'citation': 'Studnicka J. [The diabetic macular edema--new possibilities of the treatment]. Cesk Slov Oftalmol. 2012 May;68(2):61-3. Czech.'}, {'pmid': '7831044', 'type': 'BACKGROUND', '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': '19068374', 'type': 'BACKGROUND', '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': '15111519', 'type': 'BACKGROUND', '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': '25816765', 'type': 'BACKGROUND', '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': '24852439', 'type': 'BACKGROUND', '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': '25935789', 'type': 'BACKGROUND', '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': '25125075', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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 . .', 'detailedDescription': '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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1or type 2 Diabetes Mellitus.\n* Fundus examination and optical coherence tomography can be done with no significant hazy media\n\nExclusion Criteria:\n\n1. Previous ocular surgery (e.g. vitreo-retinal surgery, glaucoma surgery).\n2. Presence of co-existing retinal or choroidal disease (e.g. high myopia, retinitis pigmentosa and Age-related macular degeneration)\n3. Other associated ocular conditions (ex. glaucoma \\& corneal opacity \\& iritis).\n4. Previous history of trauma.\n5. Pregnancy induced diabetes'}, 'identificationModule': {'nctId': 'NCT03240458', 'briefTitle': 'Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Screening For Diabetic Macular Edema Among Diabetic Patients In Assiut University Hospital Using Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'DMEDP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'description': 'an objective non-invasive method for high-resolution cross-sectional imaging of the retina'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gamal N Mahmoud, professor', 'role': 'CONTACT', 'email': 'gamalnouby@live.com', 'phone': '02201223211939'}, {'name': 'Mohammed S Abd-el Rahman, professor', 'role': 'CONTACT', 'email': 'mohamed66saad@gmail.com', 'phone': '0221222414233'}], 'overallOfficials': [{'name': 'Mohammed A Sayed, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investgator', 'investigatorFullName': 'Sara maksoud', 'investigatorAffiliation': 'Assiut University'}}}}