Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT05104294
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.', 'timeFrame': 'Immediately after OCTA and electroretinogram diagnostic tests for each eye.', 'description': 'Correlation between RNFL thickness and GCC measured by OCT-A with implicit time and amplitude of Photopic Negative Response (PhNR) measured by electroretinogram.'}], 'secondaryOutcomes': [{'measure': 'Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.', 'timeFrame': 'Immediately after OCTA and electroretinogram diagnostic tests for each eye.', 'description': 'Changes in the parameters were measured by OCT-A as Superficial and deep vessel Density.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open angle glaucoma', 'Optical coherence Tomography', 'Photopic negative response'], 'conditions': ['Open Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '36441346', 'type': 'DERIVED', 'citation': 'Tabl AA, Tabl MA. Correlation between OCT-angiography and photopic negative response in patients with primary open angle glaucoma. Int Ophthalmol. 2023 Jun;43(6):1889-1901. doi: 10.1007/s10792-022-02588-9. Epub 2022 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.', 'detailedDescription': "Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.\n\nOCT Angiography (OCTA) is a promising tool for diagnosing and monitoring glaucomatous patients. It can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina Correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (RNFL) and macular/ganglion cell complex (GCC) can lead to early detection of glaucomatous changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'One hundreds fifty-two eyes of 76 participants were included in this study, with the participants recruited from the outpatient glaucoma clinic of Benha University Hospital, EGYPT.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 30 years or older for both control and glaucoma groups.\n* Spherical equivalent (SE) between -2 and +2 D.\n* No history of previous eye surgery, trauma, or systemic diseases.\n\nExclusion Criteria:\n\n* Spherical equivalent greater than +/- 2.00 diopters (D).\n* Media opacity as (cataract or corneal scar).\n* Any history of ocular surgeries or trauma.\n* Optic nerve anomaly or other retinal diseases.\n* Unreliable visual field tests (33% fixation losses, false positive, and false- negative results).'}, 'identificationModule': {'nctId': 'NCT05104294', 'briefTitle': 'Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'RC-9-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild Primary Open Angle Glaucoma group (Group I)', 'description': '28 eyes of 16 patients with mild primary open angle glaucoma as group I.', 'interventionNames': ['Diagnostic Test: Optical Coherence Tomography- Angiography', 'Diagnostic Test: Photopic negative response']}, {'label': 'moderate to severe Primary Open Angle Glaucoma group (Group II)', 'description': '44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II.', 'interventionNames': ['Diagnostic Test: Optical Coherence Tomography- Angiography', 'Diagnostic Test: Photopic negative response']}, {'label': 'Control Group', 'description': '80 eyes of 40 healthy subjects as control group.', 'interventionNames': ['Diagnostic Test: Optical Coherence Tomography- Angiography', 'Diagnostic Test: Photopic negative response']}], 'interventions': [{'name': 'Optical Coherence Tomography- Angiography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OCT-A'], 'description': 'Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.', 'armGroupLabels': ['Control Group', 'mild Primary Open Angle Glaucoma group (Group I)', 'moderate to severe Primary Open Angle Glaucoma group (Group II)']}, {'name': 'Photopic negative response', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PhNR'], 'description': 'Both the implicit time and amplitude of PhNR were recorded.', 'armGroupLabels': ['Control Group', 'mild Primary Open Angle Glaucoma group (Group I)', 'moderate to severe Primary Open Angle Glaucoma group (Group II)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Benha', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Marwa A Tabl, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology', 'investigatorFullName': 'Ahmed Abdelshafy', 'investigatorAffiliation': 'Benha University'}}}}