Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT00769392
Status:
COMPLETED
Last Update Posted:
2020-03-09
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christine.gould@lahey.org', 'phone': '781-744-2580', 'title': 'Gregory Blaha, MD', 'organization': 'Lahey Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations of any study examining pain are the subjective nature of pain, the difficulty in measurement, and patient variability. This was address by using a randomized block design.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event frequency was monitored from the time of participant consent to the end of the study at 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 13, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Subconjunctival Hemorrage with Lidocaine subconjunctival injection', 'notes': 'Subconjunctival Hemorrage occurrence with Lidocaine subconjunctival injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Discomfort Associated With the Intravitreal Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).'}], 'classes': [{'title': 'Lidocaine 4%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Lidocaine 2% Injectable Solution', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Proparacaine Ophthalmic', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Tetracaine Ophthalmic', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000'], 'groupDescription': 'A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.', 'statisticalMethod': 'single factor analysis of variance', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Discomfort From Anesthesia Used Prior to Intravitreal Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).'}], 'classes': [{'title': 'Lidocaine 4%', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Lidocaine 2% Injectable Solution', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Proparacaine Ophthalmic', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Tetracaine Ophthalmic', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000'], 'groupDescription': 'A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.', 'statisticalMethod': 'single factor analysis of variance', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All participants received, in an randomized cross-over fashion, Proparacaine drops, Tetracaine drops, Lidocaine 4% soaked cotton sponge, and Lidocaine 2% subconjunctival injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '28 participants enrolled in this study. Once 24 subjects completed the study, the remaining 4 subjects were not required to complete the study, therefore, their data was not collected for this analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '28 participants enrolled in this study. Once 24 subjects completed the study, the remaining 4 subjects were not required to complete the study and their data was not used in this analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2009-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2008-10-08', 'resultsFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2008-10-08', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-19', 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discomfort Associated With the Intravitreal Injection', 'timeFrame': '16 weeks', 'description': 'Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)'}], 'secondaryOutcomes': [{'measure': 'Discomfort From Anesthesia Used Prior to Intravitreal Injections', 'timeFrame': '16 weeks', 'description': 'Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Degeneration', 'Intravitreal injections', 'Eye anesthesia-Topical/subconjunctival', 'Eye-surgical procedures', 'Ophthalmologic anesthesia methods'], 'conditions': ['Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '17061223', 'type': 'BACKGROUND', 'citation': 'Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. doi: 10.1177/112067210601600509.'}, {'pmid': '18306942', 'type': 'BACKGROUND', 'citation': 'Landry DA. Topical anesthetic pledgett system (TAPS) for intravitreal injection preparation. Insight. 2007 Oct-Dec;32(4):20.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.', 'detailedDescription': "Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections.\n\nPatients who have received prior injections and are scheduled to continue regular injections will be randomized to utilize one of four types of anesthetic treatment for each of 4 treatment periods,so that each subject receives all four types of anesthesia over the course of the study. The order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. This will decrease the effect of extraneous variables from influencing subjective pain scores.\n\nFollowing each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving both the anesthesia and the injection(on separate 0-10 scales).\n\nThe anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine.\n\nThe subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female \\> 40 years of age\n* Diagnosis of age-related macular degeneration\n* History of at least 1 intravitreal injection in the past in either eye\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)"}, 'identificationModule': {'nctId': 'NCT00769392', 'briefTitle': 'Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection', 'organization': {'class': 'OTHER', 'fullName': 'Lahey Clinic'}, 'officialTitle': 'Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection', 'orgStudyIdInfo': {'id': '2008-076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Participants', 'description': 'All Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparacaine Ophthalmic drops used prior to Injection 1; Tetracaine Ophthalmic drops used prior to Injection 2; Lidocaine 4% sponge used prior to Injection 3; Lidocaine 2% injectable solution (subconjunctival) used prior to Injection 4).', 'interventionNames': ['Drug: Proparacaine Ophthalmic', 'Drug: Tetracaine Ophthalmic', 'Drug: Lidocaine 4%', 'Drug: Lidocaine 2% Injectable Solution']}], 'interventions': [{'name': 'Proparacaine Ophthalmic', 'type': 'DRUG', 'description': 'Drops of Proparacaine on the eye, administered as described in the package insert', 'armGroupLabels': ['All Participants']}, {'name': 'Tetracaine Ophthalmic', 'type': 'DRUG', 'description': 'Drops of Tetracaine on the eye, administered as described in the package insert', 'armGroupLabels': ['All Participants']}, {'name': 'Lidocaine 4%', 'type': 'DRUG', 'description': 'A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva', 'armGroupLabels': ['All Participants']}, {'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'description': 'A subconjunctival injection of Lidocaine 2%', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02474', 'city': 'Arlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Arlington', 'geoPoint': {'lat': 42.41537, 'lon': -71.15644}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic, Inc.', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01960', 'city': 'Peabody', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Northshore', 'geoPoint': {'lat': 42.52787, 'lon': -70.92866}}], 'overallOfficials': [{'name': 'Gregory R. Blaha, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahey Clinic, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahey Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}