Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-03-11 @ 9:56 AM
Study NCT ID:
NCT02497092
Status:
UNKNOWN
Last Update Posted:
2016-04-19
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Intravitreal Injection Techniques and Pain Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-17', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain during the injection as measured by the "Pain numeric rating scale"', 'timeFrame': 'Up to 2 minutes after the injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Injection Site Discomfort']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections\n* Informed consent\n\nExclusion Criteria:\n\n* Dementia or any other reason for cognitive deterioration\n* Technical limitations not allowing injecting by the protocol'}, 'identificationModule': {'nctId': 'NCT02497092', 'briefTitle': 'Different Intravitreal Injection Techniques and Pain Level', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Effect of Different Injection Techniques on Pain Level in Intravitreal Injections', 'orgStudyIdInfo': {'id': '0021-15-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Slow angled injection', 'description': 'Slow and angled insertion of the needle through the sclera', 'interventionNames': ['Other: Technique of injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Slow straight injection', 'description': 'Slow and straight insertion of the needle through the sclera', 'interventionNames': ['Other: Technique of injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fast angled injection', 'description': 'fast and angled insertion of the needle through the sclera', 'interventionNames': ['Other: Technique of injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fast straight injection', 'description': 'fast and straight insertion of the needle through the sclera', 'interventionNames': ['Other: Technique of injection']}], 'interventions': [{'name': 'Technique of injection', 'type': 'OTHER', 'armGroupLabels': ['Fast angled injection', 'Fast straight injection', 'Slow angled injection', 'Slow straight injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amir Sternfeld, MD', 'role': 'CONTACT', 'email': 'shtery@gmail.com', 'phone': '972-50-7665980'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Amir Sternfeld, MD', 'role': 'CONTACT', 'email': 'shtery@gmail.com', 'phone': '972-50-7665980'}], 'overallOfficials': [{'name': 'Amir Sternfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Amir Sternfeld', 'investigatorAffiliation': 'Rabin Medical Center'}}}}