Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT01600261
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2012-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCam Clinical Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of clinically useful images', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['without eye disease'], 'conditions': ['Eye Disease']}, 'descriptionModule': {'briefSummary': 'Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.', 'detailedDescription': 'Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects shall be recruited from the practice of the principal investigator (PI).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Able and willing to complete the required examination\n\nExclusion Criteria:\n\n* Spherical Equivalent outside -12 diopter to +15 diopter\n* Without lens\n* Inability to fixate'}, 'identificationModule': {'nctId': 'NCT01600261', 'briefTitle': 'iCam Clinical Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'iCam Clinical Validation Study', 'orgStudyIdInfo': {'id': '200-47425'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eye exam'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94550', 'city': 'Livermore', 'state': 'California', 'country': 'United States', 'facility': 'Livermore Optometry Group', 'geoPoint': {'lat': 37.68187, 'lon': -121.76801}}, {'zip': '95112', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Buena Vista Eye Care', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}