Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-26 @ 10:48 PM
Study NCT ID:
NCT00366769
Status:
COMPLETED
Last Update Posted:
2006-08-21
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Outcomes Following LASIK Surgery Using CustomVue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2006-08-17', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity'}, {'measure': 'Induction of high order aberrations'}], 'secondaryOutcomes': [{'measure': 'Contrast sensitivity & glare'}, {'measure': 'Patient satisfaction'}]}, 'conditionsModule': {'conditions': ['Myopia', 'Astigmatism', 'Myopic Astigmatism']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myopia 0.00 to -6.00 D\n* Astigmatism 0.00 up to -3.00 D\n* Manifest refraction spherical equivalent (MRSE) up to -6.00 D.\n\nExclusion Criteria:\n\n* History of ocular pathology\n* Previous ocular surgery\n* Large pupils (greater than 8mm diameter, infrared measurement)\n* Thin corneas (preoperatively calculated minimal residual bed \\< 250 um)\n* Irregular astigmatism\n* Asymmetric astigmatism\n* Unstable refraction\n* Any other condition that precludes the patient from undergoing LASIK'}, 'identificationModule': {'nctId': 'NCT00366769', 'briefTitle': 'Evaluation of Outcomes Following LASIK Surgery Using CustomVue', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue', 'orgStudyIdInfo': {'id': 'MRC-05-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wavefront-guided LASIK using CustomVue platform', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kerry D. Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}}}}