Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT00404105
Status:
COMPLETED
Last Update Posted:
2006-11-27
First Post:
2006-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of PRK and 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2006-11-24', 'studyFirstSubmitDate': '2006-11-24', 'studyFirstSubmitQcDate': '2006-11-24', 'lastUpdatePostDateStruct': {'date': '2006-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected visual acuity'}, {'measure': 'Best corrected visual acuity'}, {'measure': 'Best spectacle correction'}], 'secondaryOutcomes': [{'measure': 'IOP'}, {'measure': 'Corneal thickness'}, {'measure': 'Corneal wavefront aberrations'}]}, 'conditionsModule': {'keywords': ['Excimer laser'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '22879417', 'type': 'DERIVED', 'citation': 'Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.'}]}, 'descriptionModule': {'briefSummary': 'The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spherical equivalent subjective refraction between -6.00 and -8.00 diopters\n* age between 18 and 49 years\n* desire for having laser refractive surgery\n\nExclusion Criteria:\n\n* present or past eye disease excluding myopia\n* pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT00404105', 'briefTitle': 'A Comparison of PRK and LASIK for Correction of Myopia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia', 'orgStudyIdInfo': {'id': 'AUH-Ophthalmology-1999-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PRK', 'type': 'PROCEDURE'}, {'name': 'LASIK', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Ophthalmology, Aarhus Sygehus NBG', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Jesper Hjortdal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Aarhus Sygehus, University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}}}}