Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT06759168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dry eye after cataract surgery', 'timeFrame': '1 week, 1 month and 3 months', 'description': 'The incidence of new or working dry eye symptoms following cataract surgery'}], 'secondaryOutcomes': [{'measure': 'risk factors to dry eye', 'timeFrame': '1 month', 'description': 'Identification of risk factors associated with postoperative dry eye'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Cataract surgery'], 'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '12160808', 'type': 'BACKGROUND', 'citation': 'Ram J, Gupta A, Brar G, Kaushik S, Gupta A. Outcomes of phacoemulsification in patients with dry eye. J Cataract Refract Surg. 2002 Aug;28(8):1386-9. doi: 10.1016/s0886-3350(02)01387-1.'}, {'pmid': '38992580', 'type': 'BACKGROUND', 'citation': 'Shaaban YM, Aziz BF. Tear film assessment before and after phacoemulsification in patients with age-related cataracts. BMC Ophthalmol. 2024 Jul 11;24(1):280. doi: 10.1186/s12886-024-03542-2.'}]}, 'descriptionModule': {'briefSummary': 'Relation between dry eye and cataract', 'detailedDescription': 'Study the impact of cataract surgery on the incidence and progression of dry eye disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Both males and females above 40- year old going cataract surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged above 40-years old undergoing cataract surgery\n* patients without dry eye disease\n* patients with mild to moderate degree of dry eye disease Both gender, male and female\n\nExclusion Criteria:\n\n* patients aged less 40-year old undergoing cataract surgery\n* patients with severe degrees of dry eye disease\n* patients with autoimmune disease\n* patients with chronic blepharitis'}, 'identificationModule': {'nctId': 'NCT06759168', 'briefTitle': 'Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease', 'orgStudyIdInfo': {'id': 'Dry eye & cataract surgery'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara Nabil Habeb, resident doctor', 'role': 'CONTACT', 'email': 'saranabilhabeb@gmail.com', 'phone': '+201066257137'}, {'name': 'Wael Mohammed Soliman, Professor doctor', 'role': 'CONTACT', 'email': 'warl.soliman@med.aun.edu.eg', 'phone': '+201065566530'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Sara Nabil Habeb', 'investigatorAffiliation': 'Assiut University'}}}}