Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-02 @ 7:55 AM
Study NCT ID:
NCT01481792
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2011-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ReLEx Smile for Laser 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2011-11-23', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': 'Refraction one year after surgery', 'description': 'Achieved change in refraction (spherical equivalent, SE) in diopters will be compared with attempted change in refraction (SE) in diopters. Data will be reported as fraction of eyes within an error (achieved - attempted) of +/- 0.5 diopters (SE) and within an error of +/- 1 diopters (SE).'}, {'measure': 'Safety', 'timeFrame': 'One year after surgery', 'description': 'Data will be reported as:\n\n* Percentage of eyes with best spectacle corrected visual acuity (BSCVA) worse than 20/40 for eyes with BSCVA of 20/20 or better before survey\n* Percentage of eyes that lose 2 Snellen lines or more of BSCVA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keratorefractive Surgical Procedures'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.', 'detailedDescription': 'Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital.\n\nThe patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for keratorefractive surgical correction of myopia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for keratorefractive correction of myopia\n* Patient consent to undergo keratorefractive correction of myopia\n\nExclusion Criteria:\n\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01481792', 'briefTitle': 'Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction', 'orgStudyIdInfo': {'id': 'AUH-Ophthalmology-2011-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Ophthalmology, Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, consultant, MD, PhD', 'investigatorFullName': 'Jesper Hjortdal', 'investigatorAffiliation': 'University of Aarhus'}}}}