Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-17 @ 10:55 AM
Study NCT ID:
NCT02872012
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cryoanesthesia for Intravitreal Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'arshah@med.umich.edu', 'phone': '734-763-8122', 'title': 'Dr. Anjali Shah', 'organization': 'University of Michigan Kellogg Eye Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days after treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Standard of Care: Lidocaine Gel', 'description': 'Participants randomized to this arm will have their other eye receive anesthesia via one current standard of care treatment method (lidocaine gel) prior to receiving an intravitreal injection.\n\nLidocaine gel: Lidocaine gel applied to the non-cryoanesthesia eye.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Injection Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'OG001', 'title': 'Cyroanesthesia Device -5 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'OG002', 'title': 'Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'OG003', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'OG004', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'OG005', 'title': 'Standard of Care: Lidocaine', 'description': 'Participants randomized to this arm will have their other eye receive anesthesia via the current standard of care treatment method (lidocaine) prior to receiving an intravitreal injection.\n\nLidocaine: Lidocaine will be applied to the non-cryoanesthesia eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '0.8', 'groupId': 'OG004'}, {'value': '2.3', 'spread': '0.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the intravitreal injection', 'description': "Immediately after receiving the intravitreal injection, patient's will be asked to rate their pain on the Visual Analogue (Pain) Scale. The scale ranges from 0 to 10. 0 meaning no pain and 10 meaning the worst possible pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'FG001', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds..'}, {'id': 'FG002', 'title': 'Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'FG003', 'title': 'Cyroanesthesia Device -10 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'FG004', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '23 participants were recruited. Each participant received 1 cryoanesthesia intervention in one eye and one standard of care lidocaine intervention in their other eye.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'BG001', 'title': 'Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'BG002', 'title': 'Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'BG003', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'BG004', 'title': 'Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine.\n\nComment: Cryoanesthesia Device is the name of the device.\n\nCryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.\n\nPatients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-04-11', 'size': 1289701, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-21T20:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2016-06-02', 'resultsFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-25', 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Injection Pain', 'timeFrame': 'Immediately following the intravitreal injection', 'description': "Immediately after receiving the intravitreal injection, patient's will be asked to rate their pain on the Visual Analogue (Pain) Scale. The scale ranges from 0 to 10. 0 meaning no pain and 10 meaning the worst possible pain."}]}, 'oversightModule': {'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ocular Anesthesia']}, 'referencesModule': {'references': [{'pmid': '32446842', 'type': 'DERIVED', 'citation': 'Besirli CG, Smith SJ, Zacks DN, Gardner TW, Pipe KP, Musch DC, Shah AR. Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections. Ophthalmol Retina. 2020 Oct;4(10):979-986. doi: 10.1016/j.oret.2020.04.001. Epub 2020 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the surface of the eye immediately prior to intraocular injections.\n\nThe investigators plan to carry out a pilot study to collect preliminary data on the effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal injections (IVT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral macular disease due to either exudative macular degeneration or diabetic retinopathy requiring bilateral intravitreal injections\n* Have had at least one prior intravitreal injection\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Unilateral disease\n* Unable to provide consent\n* Preexisting conjunctival, episcleral or scleral defects or disease'}, 'identificationModule': {'nctId': 'NCT02872012', 'briefTitle': 'Cryoanesthesia for Intravitreal Injections', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Cryoanesthesia for Intravitreal Injections', 'orgStudyIdInfo': {'id': 'HUM00105826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoanesthesia Device -5 degrees Celsius for 10 seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.', 'interventionNames': ['Device: Cryoanesthesia device']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoanesthesia Device -5 degrees Celsius for 20 seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.', 'interventionNames': ['Device: Cryoanesthesia device']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoanesthesia Device -7 degrees Celsius for 20 seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.', 'interventionNames': ['Device: Cryoanesthesia device']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoanesthesia Device -10 degrees Celsius for 10 seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.', 'interventionNames': ['Device: Cryoanesthesia device']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoanesthesia Device -10 degrees Celsius for 20 seconds', 'description': 'All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection.\n\nComment: Cryoanesthesia Device is the name of the device.', 'interventionNames': ['Device: Cryoanesthesia device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Participants randomized to this arm will have their other eye receive anesthesia via the current standard of care treatment method (lidocaine) prior to receiving an intravitreal injection.\n\nLidocaine: Lidocaine will be applied to the non-cryoanesthesia eye.', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Cryoanesthesia device', 'type': 'DEVICE', 'description': 'The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.', 'armGroupLabels': ['Cryoanesthesia Device -10 degrees Celsius for 10 seconds', 'Cryoanesthesia Device -10 degrees Celsius for 20 seconds', 'Cryoanesthesia Device -5 degrees Celsius for 10 seconds', 'Cryoanesthesia Device -5 degrees Celsius for 20 seconds', 'Cryoanesthesia Device -7 degrees Celsius for 20 seconds']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine applied to the non-cryoanesthesia eye.', 'armGroupLabels': ['Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Anjali R Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instructor in Ophthalmology and Visual Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Ophthalmology and Visual Sciences', 'investigatorFullName': 'Anjali Shah', 'investigatorAffiliation': 'University of Michigan'}}}}