Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT04693260
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014792', 'term': 'Visual Acuity'}], 'ancestors': [{'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Departure from scheduled follow-up visits with clinical confirmation', 'timeFrame': 'Approximately 21 Weeks', 'description': 'Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted.'}], 'secondaryOutcomes': [{'measure': 'Measure rapidly changing visual acuity', 'timeFrame': 'Approximately 21 Weeks', 'description': 'Ability to track and measure visual acuity with the EyeQue Insight in patients with rapidly changing visual acuity during the first month of Ortho-K introduction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['myopia', 'Ortho-k', 'vision'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.', 'detailedDescription': 'A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female\n2. Ages =\\>7 y.o.\n3. Subjects that are minors (\\<18 years old) must have a parent or legal guardian.\n4. Binocular vision\n5. Willing and able to give informed consent and follow all study procedures and requirements\n6. Fluent in English\n7. Be treated for myopia with Ortho-K, day contacts, or night contacts\n\nExclusion Criteria:\n\n1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.\n2. Has traveled outside the country within the last 4 weeks\n3. Medications:\n\n a. Taking medications that may affect ability to follow instructions.\n4. Eye Disease:\n\n a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.\n5. Subjects that:\n\n 1. Lack physical dexterity to properly operate the EyeQue App on the smartphone\n 2. Lack the ability to follow instruction\n 3. Lack binocular vision\n 4. Lack the ability to maintain both eyes open\n 5. Had eye surgery within the last 12 months (including Lasik)'}, 'identificationModule': {'nctId': 'NCT04693260', 'briefTitle': 'A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeQue Corp.'}, 'officialTitle': 'A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight', 'orgStudyIdInfo': {'id': 'EYEQUE - 007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hand-held Device Supported by Mobile Application', 'description': 'Insight device ETDRS measurement compared to a standard ETDRS chart', 'interventionNames': ['Device: Visual Acuity with a Hand-held Device Supported by Mobile App.']}], 'interventions': [{'name': 'Visual Acuity with a Hand-held Device Supported by Mobile App.', 'type': 'DEVICE', 'description': 'The Insight will be compared to a standard ETDRS eyechart', 'armGroupLabels': ['Hand-held Device Supported by Mobile Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Eye Boutique Optometry', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeQue Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eye Boutique Optometry', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}