Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT00713856
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2008-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-15', 'studyFirstSubmitDate': '2008-07-08', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Manifest refraction', 'timeFrame': '6 months'}, {'measure': 'Wavefront aberration value', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.', 'detailedDescription': 'Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients deemed to be suitable candidates for bilateral PRK\n\nExclusion Criteria:\n\n* Patients desiring monovision correction rather than bilateral distance correction'}, 'identificationModule': {'nctId': 'NCT00713856', 'briefTitle': 'Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Comparison of Conventional and Custom With Iris Registration PRK Ablations: Assessment of Visual Function and Patient Satisfaction', 'orgStudyIdInfo': {'id': '25339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Procedure: Custom PRK with iris registration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Procedure: Conventional PRK']}], 'interventions': [{'name': 'Custom PRK with iris registration', 'type': 'PROCEDURE', 'description': 'PRK', 'armGroupLabels': ['1']}, {'name': 'Conventional PRK', 'type': 'PROCEDURE', 'description': 'PRK', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, John Moran Eye Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Mark Mifflin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mark Mifflin, MD', 'oldOrganization': 'University of Utah'}}}}