Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05238233
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2022-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Wearing-Off Period of Pharmacological Dilation and Anisocoria
Sponsor:
Organization:
Raw JSON
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'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aimee.hanvey@prismahealth.org', 'phone': '864-760-7350', 'title': 'Aimee Hanvey', 'organization': 'Prisma Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Eye Dilation and Constriction', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.\n\nTropicamide: One drop will be given to participants\n\n1% Pilocarpine: One drop will be given to participants\n\nProparacaine Hydrochloride: One drop will be given to participants\n\nTono pen AVIA: Participant intraocular pressures measured\n\nVG4 Gonio: Participant iridocorneal angle measured\n\nReichert phoropter: Participant screened for hyperopia \\>+1 diopter', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eye Dilation and Constriction', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.\n\nTropicamide: One drop will be given to participants\n\n1% Pilocarpine: One drop will be given to participants\n\nProparacaine Hydrochloride: One drop will be given to participants\n\nTono pen AVIA: Participant intraocular pressures measured\n\nVG4 Gonio: Participant iridocorneal angle measured\n\nReichert phoropter: Participant screened for hyperopia \\>+1 diopter'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Measurement of pupil diameter', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eye Dilation and Constriction - Left Eye', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.\n\nTropicamide: One drop will be given to participants\n\n1% Pilocarpine: One drop will be given to participants\n\nProparacaine Hydrochloride: One drop will be given to participants\n\nTono pen AVIA: Participant intraocular pressures measured\n\nVG4 Gonio: Participant iridocorneal angle measured\n\nReichert phoropter: Participant screened for hyperopia \\>+1 diopter'}, {'id': 'FG001', 'title': 'Eye Dilation and Constriction - Right Eye', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.\n\nTropicamide: One drop will be given to participants\n\n1% Pilocarpine: One drop will be given to participants\n\nProparacaine Hydrochloride: One drop will be given to participants\n\nTono pen AVIA: Participant intraocular pressures measured\n\nVG4 Gonio: Participant iridocorneal angle measured\n\nReichert phoropter: Participant screened for hyperopia \\>+1 diopter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '10'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eye'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Eye Dilation and Constriction', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.\n\nTropicamide: One drop will be given to participants\n\n1% Pilocarpine: One drop will be given to participants\n\nProparacaine Hydrochloride: One drop will be given to participants\n\nTono pen AVIA: Participant intraocular pressures measured\n\nVG4 Gonio: Participant iridocorneal angle measured\n\nReichert phoropter: Participant screened for hyperopia \\>+1 diopter'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-04-08', 'size': 179696, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-13T14:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2022-02-03', 'resultsFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-13', 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye', 'timeFrame': '4 hours', 'description': 'Measurement of pupil diameter'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anisocoria']}, 'descriptionModule': {'briefSummary': 'Students at the School of Medicine Greenville will be asked to participate in this study.\n\nThe aim of this study is to better understand when medical imaging is needed for patients with anisocoria (unequal pupil size).\n\nParticipation in the study includes up to 3 visits over a period of one week. Each study visit will last about 30 minutes.\n\nAt the first visit, participants will be screened for hyperopia using a phoropter, have their intraocular pressures taken using a tono-pen, and have their iridocorneal angle measured using gonioscopy at the ophthalmology clinic. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens exam. Participants will also be asked to complete three forms.\n\nParticipants will be asked to return to the clinic on a scheduled day within one week of the screening visit to have their left eye dilated. At this visit, the diameter of the pupil will be measured using a Near card in a windowless room with a set light-level. Then, the participant will receive one drop of tropicamide in the left eye. After the drops have had time to take effect, which will be about 20-30 minutes later, the diameter of the pupil will be measured again.\n\nParticipants will then be asked to return to the clinic in 3-4 hours. At this time, the diameter of the pupil will be measured again.\n\nThe third type of eye drop used in this study is 1% pilocarpine. 1 % pilocarpine will briefly constrict the eyes. One drop of 1% pilocarpine will be administered to left eye, and the change in pupillary diameter will be measured, if any. It will take about 10-15 minutes for the 1% pilocarpine to take effect.\n\nParticipants may be required to attend 2 additional 30-minute visits on a third day depending on how their eyes respond to the drops.\n\nThis study will recruit about 10-15 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student at the University of South Carolina School of Medicine Greenville\n* Healthy participants\n* No significant ophthalmological history\n\nExclusion Criteria:\n\n* a history of angle closure glaucoma, any other type of glaucoma\n* any elevated eye pressure readings\n* any history of intraocular surgery or procedure.\n* if the participant is found to be hyperopic to \\>+1 diopter, has an intraocular pressure of \\> 22 mm Hg in either eye, or displays an iridocorneal angle where trabecular meshwork\n* known allergy to natural rubber latex'}, 'identificationModule': {'nctId': 'NCT05238233', 'briefTitle': 'Wearing-Off Period of Pharmacological Dilation and Anisocoria', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria', 'orgStudyIdInfo': {'id': '1864081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Dilation and Constriction', 'description': 'Participants screened for hyperopia \\>+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.\n\nProparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.\n\nThe following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.\n\nIf the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye.', 'interventionNames': ['Drug: Tropicamide', 'Drug: 1% Pilocarpine', 'Drug: Proparacaine Hydrochloride', 'Device: Tono pen AVIA', 'Device: VG4 Gonio', 'Device: Reichert phoropter']}], 'interventions': [{'name': 'Tropicamide', 'type': 'DRUG', 'description': 'One drop will be given to participants', 'armGroupLabels': ['Eye Dilation and Constriction']}, {'name': '1% Pilocarpine', 'type': 'DRUG', 'description': 'One drop will be given to participants', 'armGroupLabels': ['Eye Dilation and Constriction']}, {'name': 'Proparacaine Hydrochloride', 'type': 'DRUG', 'description': 'One drop will be given to participants', 'armGroupLabels': ['Eye Dilation and Constriction']}, {'name': 'Tono pen AVIA', 'type': 'DEVICE', 'description': 'Participant intraocular pressures measured', 'armGroupLabels': ['Eye Dilation and Constriction']}, {'name': 'VG4 Gonio', 'type': 'DEVICE', 'description': 'Participant iridocorneal angle measured', 'armGroupLabels': ['Eye Dilation and Constriction']}, {'name': 'Reichert phoropter', 'type': 'DEVICE', 'description': 'Participant screened for hyperopia \\>+1 diopter', 'armGroupLabels': ['Eye Dilation and Constriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}