Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT01220193
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2010-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of RTVue in Corneal Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2010-10-11', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Normal Cornea', 'Post Laser Refractive Surgery', 'Cornea Pathology', 'Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Various ocular conditions to include normal, pathology, post refractive surgery and cataract.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNormal cornea:\n\n* 18 years of age or older\n* No corneal pathology\n* No prior ocular surgery and no prior laser refractive surgery\n\nPost laser refractive surgery:\n\n* 18 years of age or older\n* No corneal pathology\n* No prior ocular surgery except laser refractive surgery\n* At least 1 week post laser refractive surgery without complication\n\nCorneal pathology:\n\n* 18 years of age or older\n* Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)\n* No prior laser refractive surgery\n\nCataract surgery:\n\n* 18 years of age or older\n* No corneal pathology\n* No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery\n* Post surgery visit shall only include eyes without complication'}, 'identificationModule': {'nctId': 'NCT01220193', 'briefTitle': 'Evaluation of RTVue in Corneal Measurement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'Evaluation of RTVue in Corneal Measurement', 'orgStudyIdInfo': {'id': 'RTVue 100 - 2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal cornea'}, {'label': 'Post laser refractive surgery'}, {'label': 'Cornea pathology'}, {'label': 'Cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Gordon Binder & Weiss Vision Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'Brass Eye Center', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Qienyuan Zhou, PhD', 'oldOrganization': 'Optovue'}}}}