Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-30 @ 10:48 PM
Study NCT ID:
NCT06883032
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Preference', 'timeFrame': '2 weeks', 'description': 'Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractive errors', 'eyeglasses'], 'conditions': ['Refractive Errors']}, 'referencesModule': {'references': [{'pmid': '34111444', 'type': 'BACKGROUND', 'citation': 'Joseph S, Varadaraj V, Dave SR, Lage E, Lim D, Aziz K, Dudgeon S, Ravilla TD, Friedman DS. Investigation of the Accuracy of a Low-Cost, Portable Autorefractor to Provide Well-Tolerated Eyeglass Prescriptions: A Randomized Crossover Trial. Ophthalmology. 2021 Dec;128(12):1672-1680. doi: 10.1016/j.ophtha.2021.05.030. Epub 2021 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale\n* who are aged between 18 years and 65 years\n\nExclusion Criteria:\n\n* whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C)\n* who are unable to provide consent\n* who have undergone any eye surgery\n* who have a history of ocular disease\n* who are taking systemic drugs\n* who wear more than one pair of single vision eyeglasses for distance\n* who more than occasionally wear soft contact lenses\n* who are unable and unwilling to wear the eyeglasses provided by the study for the required duration'}, 'identificationModule': {'nctId': 'NCT06883032', 'briefTitle': 'Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions', 'organization': {'class': 'INDUSTRY', 'fullName': 'PlenOptika, Inc.'}, 'officialTitle': 'Validation of the QuickSee Plus Device', 'orgStudyIdInfo': {'id': 'QuickSee Plus Trial'}, 'secondaryIdInfos': [{'id': '2R44EY025452-04', 'link': 'https://reporter.nih.gov/quickSearch/2R44EY025452-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AR Eyeglasses, then SR Eyeglasses', 'description': 'Automated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses', 'interventionNames': ['Other: AR Eyeglasses first, SR Eyeglasses second']}, {'type': 'OTHER', 'label': 'SR Eyeglasses, then AR Eyeglasses', 'description': 'Subjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses', 'interventionNames': ['Other: SR Eyeglasses first, AR Eyeglasses second']}], 'interventions': [{'name': 'AR Eyeglasses first, SR Eyeglasses second', 'type': 'OTHER', 'description': 'First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction', 'armGroupLabels': ['AR Eyeglasses, then SR Eyeglasses']}, {'name': 'SR Eyeglasses first, AR Eyeglasses second', 'type': 'OTHER', 'description': 'First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction', 'armGroupLabels': ['SR Eyeglasses, then AR Eyeglasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England College of Optometry (NECO) Center for Eye Care of Commonwealth', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'March 2025 - May 2025', 'ipdSharing': 'YES', 'accessCriteria': 'PlenOptika, New England College of Optometry, Data Safety Monitoring Board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PlenOptika, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'New England College of Optometry', 'class': 'OTHER'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO & co-founder', 'investigatorFullName': 'Shivang R. Dave, PhD', 'investigatorAffiliation': 'PlenOptika, Inc.'}}}}