Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 2:19 AM
Study NCT ID:
NCT01673503
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2012-08-20', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Corneal biomechanics, corneal nerve changes and dry eye symptoms', 'timeFrame': 'pre-surgery and 6 months after', 'description': 'Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.'}], 'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'up to 6 months', 'description': 'Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart'}], 'secondaryOutcomes': [{'measure': 'refractive predictability', 'timeFrame': 'Pre-surgery, 1 week, 1 month, 3 months, 6 months', 'description': 'Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia', 'refractive surgery', 'all femtosecond laser', 'ReLEx flex', 'ReLEx smile'], 'conditions': ['Myopia', 'Astigmatism']}, 'referencesModule': {'references': [{'pmid': '23793872', 'type': 'DERIVED', 'citation': 'Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 to 45 years,\n* moderate to high myopia with astigmatism =\\< 2 D,\n* otherwise eye healthy,\n* CDVA of 0.8 or better (Snellen).\n\nExclusion Criteria:\n\n* systemic or ocular disease or previous eye surgery,\n* thin cornea,\n* a difference of more than 2 D myopia in the eyes of each subject.'}, 'identificationModule': {'nctId': 'NCT01673503', 'briefTitle': 'A Prospective Study of Femtosecond Laser Intracorneal Lensectomi', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia', 'orgStudyIdInfo': {'id': 'S-20100111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carl Zeiss Meditech VisuMax laser - ReLEx flex', 'description': '\\>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile', 'interventionNames': ['Device: Carl Zeiss Meditech VisuMax laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carl Zeiss Meditech VisuMax laser - ReLEx smile', 'description': '\\>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile', 'interventionNames': ['Device: Carl Zeiss Meditech VisuMax laser']}], 'interventions': [{'name': 'Carl Zeiss Meditech VisuMax laser', 'type': 'DEVICE', 'otherNames': ['Refractive lenticule extraction, ReLEx'], 'description': 'Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser', 'armGroupLabels': ['Carl Zeiss Meditech VisuMax laser - ReLEx flex', 'Carl Zeiss Meditech VisuMax laser - ReLEx smile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Anders H Vestergaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital, University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Anders H. Vestergaard', 'investigatorAffiliation': 'University of Southern Denmark'}}}}