Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT05871034
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroretinogram and Retinal Vascular Changes After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-10', 'releaseDate': '2025-09-23'}], 'estimatedResultsFirstSubmitDate': '2025-09-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-13', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-13', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma', 'timeFrame': 'before operation and 1st month, 3rd month post operative', 'description': 'electrophysiology and optical coherence tomography angiography changes'}], 'secondaryOutcomes': [{'measure': 'Visual acuity and intra ocular pressure changes', 'timeFrame': 'before operation and 1st month, 3rd month post operative', 'description': 'visual acuity and intraocular pressure changes'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OCTA: optical coherence tomography angiography', 'ERG: electroretinogram', 'POAG: primary open Angle glaucoma', 'V/A: visual acuity', 'IOP: intra ocular pressure'], 'conditions': ['Primary Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'To compare electrophysiological and Optical coherence tomography angiography of optic disc and macula changes after uneventful phacoemulsification between normal and cataractus patients with primary open angle glaucoma.', 'detailedDescription': "* Study design: A prospective, non randomized, interventional, comparative study, control based study.\n* Location: Ophthalmology department, Sohag university hospital. In this prospective study, aiming to investigate Optical coherence tomography angiography and electrophysiological changes after cataract surgery in normal and patients with POAG with cataract 1 day before operation, 1 week and 3 months postoperatively.\n* Methodology The study will include 50 patients with primary open angle glaucoma associated with cataract and 50 patients have cataract without glaucoma.\n\nPreoperative and postoperative evaluation:\n\nAll patients will be subjected to the following:\n\n* History taking including age, gender, family history, systemic diseases, previous medications or ophthalmic surgery.\n* Detailed ophthalmological examination including: Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) by Snellen's fraction and converted into logarithm of the minimal angle of resolution LogMAR, refraction, keratometry, slit lamp biomicroscopy for anterior segment, IOP measurement by applanation tonometer, and posterior segment (Fundus) examination.\n* Examination of the angle of anterior chamber by goniolens.\n* OCTA disc and macula\n* Pattern ERG and multifocal ERG\n\nSurgical techniques:\n\nPatients will be subdivided into two groups:\n\nGroup (A): normal Patients will undergo standard phacoemulsification surgery. Group (B): Patients with POAG will undergo standard phacoemulsification surgery.\n\n\\* phaco technology by using (WHITESTAR SIGNATURE PRO, Abbott, USA)\n\n* OCT angiography will be done by (Optovue, Inc., Fremont, California, USA).\n* Electrophysiology will be done by (Roland consult Retimap, Germany)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged: 45-65 years old with cataract density doesn't interfere with Pre-operative imaging (N1-N2).\n* Patients with primary open angle diagnosed for at least 2 years with glaucoma treatment associated with cataract (N1-N2).\n\nExclusion criteria:\n\ns▪ patient with PACG.\n\n* Previous intraocular surgery.\n* Associated ocular or intra ocular inflammation\n* Previous history of eye trauma.\n* Associated intraocular pathology"}, 'identificationModule': {'nctId': 'NCT05871034', 'briefTitle': 'Electroretinogram and Retinal Vascular Changes After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification', 'orgStudyIdInfo': {'id': 'SAHASSAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery', 'interventionNames': ['Procedure: phacoemulsification']}, {'type': 'OTHER', 'label': 'Open Angle glaucoma group', 'description': 'patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery', 'interventionNames': ['Procedure: phacoemulsification']}], 'interventions': [{'name': 'phacoemulsification', 'type': 'PROCEDURE', 'description': 'cataract extraction', 'armGroupLabels': ['Control group', 'Open Angle glaucoma group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'shorouq abdelrahman', 'role': 'CONTACT', 'email': 'shorouqabdelrahman2015@gmail.com', 'phone': '01016685915'}, {'name': 'alaa mahmoud', 'role': 'CONTACT', 'phone': '01060422011'}], 'overallOfficials': [{'name': 'shorouq abdelrahman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Shorouq Abdelrahman Hassan', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-23', 'type': 'RELEASE'}, {'date': '2025-10-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shorouq Abdelrahman Hassan, Assistant lecturer, Sohag University'}}}}