Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-07 @ 11:30 PM
Study NCT ID:
NCT01682434
Status:
WITHDRAWN
Last Update Posted:
2014-05-02
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wavefront-guided LASIK for Correction of Myopia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020731', 'term': 'Keratomileusis, Laser In Situ'}], 'ancestors': [{'id': 'D048988', 'term': 'Corneal Surgery, Laser'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074431', 'term': 'Keratectomy'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Institution changed surgical method to small-incision lenticule extraction. Study never started.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Ocular higher order aberrations', 'timeFrame': '12 months', 'description': 'Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.\n\nAdvances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.\n\nThe study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 to 50 years\n* No known ocular or systemic disease\n* Not pregnant or breastfeeding\n* Myopia between -6.0 and -10.0 diopters\n* Astigmatism below 2.0 diopters\n* Difference of less than 1.0 diopters in spherical equivalent between eyes\n* Normal corneal topography\n* Corneal thickness sufficient for planned treatment\n\nExclusion Criteria:\n\n* Patients that do not fulfill inclusion criteria\n* Insufficient quality of ocular wavefront measurement'}, 'identificationModule': {'nctId': 'NCT01682434', 'briefTitle': 'Wavefront-guided LASIK for Correction of Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Wavefront-guided LASIK for Correction of Myopia', 'orgStudyIdInfo': {'id': 'AUH_LASIK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wavefront-guided LASIK', 'description': 'One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.', 'interventionNames': ['Procedure: Laser in situ keratomileusis (LASIK)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional LASIK', 'description': 'One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.', 'interventionNames': ['Procedure: Laser in situ keratomileusis (LASIK)']}], 'interventions': [{'name': 'Laser in situ keratomileusis (LASIK)', 'type': 'PROCEDURE', 'otherNames': ['Device: Carl Zeiss Meditec Visumax femtosecond LASIK', 'Device: Carl Zeiss Meditec MEL-80 excimer laser.'], 'description': 'Wavefront guided treatment in one eye, conventional in the other.', 'armGroupLabels': ['Conventional LASIK', 'Wavefront-guided LASIK']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Ophthalmology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Anders Ivarsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anders Ivarsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}