Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT06689904
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2024-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-28', 'mcpReleaseN': 1, 'releaseDate': '2025-05-13'}], 'estimatedResultsFirstSubmitDate': '2025-05-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015878', 'term': 'Mydriasis'}], 'ancestors': [{'id': 'D011681', 'term': 'Pupil Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupil size (diameter)', 'timeFrame': '30 minutes after dilation', 'description': 'Pupil diameter (mm)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['eye drops', 'pupil dilation', 'eye drop bottle device', 'eye drop size'], 'conditions': ['Medication Delivery', 'Eye Drop Delivery']}, 'descriptionModule': {'briefSummary': 'The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects.\n\nThe Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.\n\nIn this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.', 'detailedDescription': 'Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.\n\nThe Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.\n\nThis is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years old\n* scheduled for routine bilateral eye dilation\n\nExclusion Criteria:\n\n* narrow angles\n* allergies to phenylephrine or tropicamide\n* concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)\n* baseline anisocoria (\\>1 mm)\n* traumatic pupil,\n* surgical pupil\n* unilateral pseudoexfoliation.'}, 'identificationModule': {'nctId': 'NCT06689904', 'briefTitle': 'The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Health'}, 'officialTitle': 'The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter', 'orgStudyIdInfo': {'id': '1826733-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye dilated with the nanodropper', 'description': 'For each participant, one eye (left or right) is randomly selected to be dilated with the Nanodropper.', 'interventionNames': ['Device: Nanodropper']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eye dilated with the standard bottle', 'description': 'Fellow eye is dilated with the standard eye drop bottle', 'interventionNames': ['Device: Standard eye drop bottle']}], 'interventions': [{'name': 'Nanodropper', 'type': 'DEVICE', 'description': 'One eye is randomly selected to be dilated with the nanodropper', 'armGroupLabels': ['Eye dilated with the nanodropper']}, {'name': 'Standard eye drop bottle', 'type': 'DEVICE', 'description': 'eye is dilated with the standard eye drop bottle', 'armGroupLabels': ['Eye dilated with the standard bottle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94012', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Lions Eye Clinic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sutter Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}