Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:15 AM
Study NCT ID:
NCT06904560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial cell count', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'incidence of anterior segment inflammation', 'timeFrame': '3 months', 'description': 'incidence of anterior segment inflammation including conjunctival hypremia or corneal edema'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cornea, cataract'], 'conditions': ['Corneal Diseases']}, 'descriptionModule': {'briefSummary': 'patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs', 'detailedDescription': 'patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cataract\n* more than 40 years\n* no glaucoma\n* no retinal abnormalities\n* no retinal abnormalities\n\nExclusion Criteria:\n\npatients with corneal diseases patients less than 40 patients with previous eye surgery'}, 'identificationModule': {'nctId': 'NCT06904560', 'briefTitle': 'The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort', 'orgStudyIdInfo': {'id': 'sohag-med-25-1-5PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group 1', 'description': 'patients underwent phacoemulsification , balanced saline solution at room temperature will be used for irrigation', 'interventionNames': ['Other: phacoemulsification']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'patients underwent phacoemulsification , balanced saline solution with low (cold ) temperature will be used for irrigation', 'interventionNames': ['Other: phacoemulsification']}], 'interventions': [{'name': 'phacoemulsification', 'type': 'OTHER', 'description': 'one group with BSS at room temperature and the other group with cold BSS', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hany Mahmoud', 'role': 'CONTACT', 'email': 'drhanymahmoud@gmail.com', 'phone': '01024368111'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of ophthalmology', 'investigatorFullName': 'Hany Mahmoud,MD', 'investigatorAffiliation': 'Sohag University'}}}}