Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT04594603
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA', 'timeFrame': '1 week after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '19465281', 'type': 'RESULT', 'citation': 'Mirshahi A, Hohn F, Lorenz K, Hattenbach LO. Incidence of posterior vitreous detachment after cataract surgery. J Cataract Refract Surg. 2009 Jun;35(6):987-91. doi: 10.1016/j.jcrs.2009.02.016.'}, {'pmid': '17208303', 'type': 'RESULT', 'citation': 'Ripandelli G, Coppe AM, Parisi V, Olzi D, Scassa C, Chiaravalloti A, Stirpe M. Posterior vitreous detachment and retinal detachment after cataract surgery. Ophthalmology. 2007 Apr;114(4):692-7. doi: 10.1016/j.ophtha.2006.08.045. Epub 2007 Jan 17.'}, {'pmid': '10724830', 'type': 'RESULT', 'citation': 'Rossetti L, Autelitano A. Cystoid macular edema following cataract surgery. Curr Opin Ophthalmol. 2000 Feb;11(1):65-72. doi: 10.1097/00055735-200002000-00010.'}, {'pmid': '10360304', 'type': 'RESULT', 'citation': 'Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.'}, {'pmid': '17275910', 'type': 'RESULT', 'citation': 'Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.'}, {'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.'}, {'pmid': '31119505', 'type': 'RESULT', 'citation': 'Sorour OA, Sabrosa AS, Yasin Alibhai A, Arya M, Ishibazawa A, Witkin AJ, Baumal CR, Duker JS, Waheed NK. Optical coherence tomography angiography analysis of macular vessel density before and after anti-VEGF therapy in eyes with diabetic retinopathy. Int Ophthalmol. 2019 Oct;39(10):2361-2371. doi: 10.1007/s10792-019-01076-x. Epub 2019 May 22.'}]}, 'descriptionModule': {'briefSummary': 'To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients', 'detailedDescription': 'A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital\n\nTwo groups will be divided:\n\n1. Group (1): Cataract will no diabetic retinopathy\n2. Group (2): Cataract associated with diabetic retinopathy.\n\nAll patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. 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 with adequate centration on the fovea and optic nerve head respectively will be selected.\n\nSegmentation 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.\n\nThe measurements of the OCTA, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. Optical coherence tomography and IOP measurements will also be obtained 1 week after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This will be a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus\n* Intraocular pressure (IOP) of 21 mm Hg or lower\n* Axial length (AL) between 20.0 mm and 25.0 mm.\n\nExclusion Criteria:\n\n* Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,\n\n * IOP higher than 21 mm Hg,\n * History of ocular trauma or intraocular surgery, or any abnormal intraocular findings\n * Poor OCT-A images because of severe cataracts or unstable fixation\n * Any signs of intraoperative or postoperative complications'}, 'identificationModule': {'nctId': 'NCT04594603', 'briefTitle': 'Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography', 'orgStudyIdInfo': {'id': '34082/9/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group(1): Cataract with no diabetic retinopathy', 'interventionNames': ['Other: Phacoemulsification for cataract']}, {'label': 'Group (2): Cataract associated with diabetic retinopathy', 'interventionNames': ['Other: Phacoemulsification for cataract']}], 'interventions': [{'name': 'Phacoemulsification for cataract', 'type': 'OTHER', 'description': 'Phacoemulsification for removal of cataract', 'armGroupLabels': ['Group (2): Cataract associated with diabetic retinopathy', 'Group(1): Cataract with no diabetic retinopathy']}]}, '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': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'accessCriteria': 'Link'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology, Tanta University, Egypt', 'investigatorFullName': 'Dina Tadros', 'investigatorAffiliation': 'Tanta University'}}}}