Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT04601805
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vascular changes in the posterior segment of patients suffering from inflammatory bowel disease using the optical coherence tomography angiography', 'timeFrame': '1 month', 'description': 'OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio withadequate centration on the fovea and optic nerve head Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).\n\nThe vessel density metric from enface OCT angiogram as an indicator of macular retinal and papillary perfusion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '28070181', 'type': 'RESULT', 'citation': 'Silva FA, Rodrigues BL, Ayrizono ML, Leal RF. The Immunological Basis of Inflammatory Bowel Disease. Gastroenterol Res Pract. 2016;2016:2097274. doi: 10.1155/2016/2097274. Epub 2016 Dec 14.'}, {'pmid': '24415861', 'type': 'RESULT', 'citation': 'Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.'}, {'pmid': '14609712', 'type': 'RESULT', 'citation': 'Ghanchi FD, Rembacken BJ. Inflammatory bowel disease and the eye. Surv Ophthalmol. 2003 Nov-Dec;48(6):663-76. doi: 10.1016/j.survophthal.2003.08.004.'}, {'pmid': '28932076', 'type': 'RESULT', 'citation': 'Troncoso LL, Biancardi AL, de Moraes HV Jr, Zaltman C. Ophthalmic manifestations in patients with inflammatory bowel disease: A review. World J Gastroenterol. 2017 Aug 28;23(32):5836-5848. doi: 10.3748/wjg.v23.i32.5836.'}, {'pmid': '17227526', 'type': 'RESULT', 'citation': "Familiari L, Strangio G, Consolo P, Luigiano C, Bonica M, Barresi G, Barresi V, Familiari P, D'Arrigo G, Alibrandi A, Zirilli A, Fries W, Scaffidi M. Optical coherence tomography evaluation of ulcerative colitis: the patterns and the comparison with histology. Am J Gastroenterol. 2006 Dec;101(12):2833-40. doi: 10.1111/j.1572-0241.2006.00826.x."}, {'pmid': '17262200', 'type': 'RESULT', 'citation': 'Yilmaz S, Aydemir E, Maden A, Unsal B. The prevalence of ocular involvement in patients with inflammatory bowel disease. Int J Colorectal Dis. 2007 Sep;22(9):1027-30. doi: 10.1007/s00384-007-0275-1. Epub 2007 Jan 30.'}, {'pmid': '29436208', 'type': 'RESULT', 'citation': 'Or C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study;To record the vascular changes that may be present in the posterior segment of patients suffering from Inflammatory bowel diseases(IBD) using the optical coherence tomography angiography', 'detailedDescription': 'a prospective study of 30 patients suffering from IBD referred from tropical department from Tanta University Hospital\n\n-Patients demographic data e.g., sex, age, concomitant systemic diseases will be recruited. Presenting symptoms, physical examination results, laboratory and imaging findings, and received treatment of IBD will be recorded. Accurate grading of disease severity will be carried out by gastroenterology specialist.\n\nAll patients will be subject to Full ophthalmologic examination and fundus imaging. Imaging will include OCTA and fundus photography. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected. Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).\n\nThe vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This will be a prospective study of 30 patients suffering from Inflammatory bowel disease referred from tropical department from Tanta University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Crohn's disease and ulcerative colitis either newly diagnosed or suffering from chronic disease on treatment will be included\n\nExclusion Criteria:\n\n* Recent ophthalmological surgery.\n\n * Low quality ophthalmological exams.\n * Refractive errors greater than + 3 or - 3 spherical.\n * Retinopathies such as diabetic retinopathy.\n * Any type of retinal degenerations or retinal dystrophy."}, 'identificationModule': {'nctId': 'NCT04601805', 'briefTitle': 'Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases', 'orgStudyIdInfo': {'id': '34002/8/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group (1) : Patient diagnosed with IBD with no treatment received', 'interventionNames': ['Device: Observation']}, {'label': 'Group(2): Patient diagnosed with IBD and received treatment for a long time', 'interventionNames': ['Device: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'DEVICE', 'description': 'We will record the vascular changes that follow the inflammatory bowel diseases', 'armGroupLabels': ['Group (1) : Patient diagnosed with IBD with no treatment received', 'Group(2): Patient diagnosed with IBD and received treatment for a long time']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31515', 'city': 'Tanta', 'state': 'El-Garbeia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dina Tadros, MD', 'role': 'CONTACT'}], 'facility': 'Tanta University Hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Dina SM Tadros, MD', 'role': 'CONTACT', 'email': 'dinasabry@rocketmail.com', 'phone': '00201224093354'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology, Tanta University, Egypt', 'investigatorFullName': 'Dina Tadros', 'investigatorAffiliation': 'Tanta University'}}}}