Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 6:13 AM
Study NCT ID:
NCT07038967
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity', 'timeFrame': '6 months post-procedure', 'description': 'Best Corrected Visual Acuity (BCVA) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Intra ocular pressure', 'timeFrame': '6 months post-procedure', 'description': 'Intra ocular pressure (IOP) will be recorded.'}, {'measure': 'Central macular thickness (CMT)', 'timeFrame': '6 months post-procedure', 'description': 'Central macular thickness (CMT) will be recorded.'}, {'measure': 'Frequency distribution of Fluorescein leakage', 'timeFrame': '6 months post-procedure', 'description': 'Frequency distribution of Fluorescein leakage will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Center', 'Diabetic Macular Edema', 'Phacoemulsification']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.', 'detailedDescription': 'Diabetic patients have been reported to have a higher prevalence of cataract and develop it at an earlier age compared with nondiabetic individuals.\n\nAccording to recent population-based studies, diabetic macular edema (DME) is the most common cause of vision loss, with the incidence of non-center-involving DME (NCIDME) being higher than that of center-involving DME (CIDME). The prevalence of NCIDME in an urban south Indian population is 10.8%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be conducted on 50 diabetic patients aged ≥18 years, both sexes, with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).\n\nExclusion Criteria:\n\n* Traumatic cataract.\n* Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.\n* Marked Asymmetry of retinopathy between both eyes.\n* Mature senile cataract or severe lens opacity.\n* Potentiality to have Phacotrabeculectomy surgery.\n* Complications during or after the surgery.'}, 'identificationModule': {'nctId': 'NCT07038967', 'briefTitle': 'Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification', 'orgStudyIdInfo': {'id': 'FMASU R127/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME)', 'interventionNames': ['Other: Coloured photography', 'Other: Fluorescein angiography', 'Other: Optical coherence tomography']}], 'interventions': [{'name': 'Coloured photography', 'type': 'OTHER', 'description': 'Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively.', 'armGroupLabels': ['Study group']}, {'name': 'Fluorescein angiography', 'type': 'OTHER', 'description': 'Fluorescein angiography will be performed preoperatively and at 3 and 6 months postoperatively. The following features will be recorded on each angiography:', 'armGroupLabels': ['Study group']}, {'name': 'Optical coherence tomography', 'type': 'OTHER', 'description': 'Optical coherence tomography (OCT) scanning will be performed using the optical coherence tomography scanner OCT (OPTOVUE OCT). OCT will be performed preoperatively and at 3 and 6 months postoperatively.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hatem F Abd Elfatah, MD', 'role': 'CONTACT', 'email': 'tito78@yahoo.com', 'phone': '00201001859927'}, {'name': 'Samah M Fawzy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tarek M Saad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hatem F Abd Elfatah, MD', 'role': 'CONTACT', 'email': 'tito78@yahoo.com', 'phone': '00201001859927'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Hatem Fawzy Abd Elfatah Abo saif', 'investigatorAffiliation': 'Ain Shams University'}}}}