Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT02376556
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D001763', 'term': 'Blepharoptosis'}, {'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective assessment of dry eye syndrome', 'timeFrame': '3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Subjective assessment of dry eye syndrome', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye syndrome', 'Blepharoplasty', 'Muller muscle resection surgery'], 'conditions': ['Dry Eye Syndrome', 'Ptosis', 'Dermatochalasis']}, 'descriptionModule': {'briefSummary': 'The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.', 'detailedDescription': 'Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.\n\nThe same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.\n\nThis data will help us assess the effect of these common surgical procedures on dry eye symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution\n* no other ophthalmic procedures planned for the patient in study period\n* ability to undergo full ophthalmic examination as stated in the study protocol\n* Ability to complete the dry eye questionnaire\n* ability to sign an informed consent form\n\nExclusion Criteria:\n\n* previous eyelid surgery\n* other orbital or lacrimal gland disease\n* concurrent use of contact lenses\n* concurrent use of Restasis\n* previous glaucoma surgery\n* use of punctual plugs\n* pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT02376556', 'briefTitle': 'The Effect of Eyelid Surgery on Dry Eye - a Prospective Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection', 'orgStudyIdInfo': {'id': 'SHEBA-14-1496-GBS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blepharoplasty', 'description': 'patients undergoing upper eyelid blepharoplasty'}, {'label': 'blepharoplasty and muller muscle resection', 'description': 'patients undergoing a combined blepharoplasty and muller muscle resection surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba_Medical_Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Guy J Ben Simon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel', 'investigatorFullName': 'Guy Ben Simon', 'investigatorAffiliation': 'Sheba Medical Center'}}}}