Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
Study NCT ID:
NCT06673992
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2024-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-02', 'studyFirstSubmitDate': '2024-10-26', 'studyFirstSubmitQcDate': '2024-11-02', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Irregular Astigmatism', 'timeFrame': 'preoperative and 6 years postoperatively', 'description': 'The swept-source anterior segment OCT (CASIA SS-1000) was utilized to acquire corneal topography measurements. In the Corneal Map mode, 16 radial cross-sectional images (512 telecentric+A-scans) were obtained within a duration of 0.3 s for each measurement. The analysis program identified and digitized the anterior and posterior corneal surfaces to evaluate distributions of corneal power and corneal height for both the anterior and posterior corneal surfaces. The unit of Corneal Irregular Astigmatism is D.'}, {'measure': 'wavefront aberration', 'timeFrame': 'preoperative and 6 years postoperatively', 'description': 'The wavefront aberrations were measured and analyzed for 6-mm pupil diameter with a Zywave aberrometer using a Hartmann-Shack sensor (Bausch \\& Lomb, US). The absolute Zernike coefficients including vertical trefoil, horizontal trefoil, vertical coma, horizontal coma, spherical aberration, and total higher-order aberrations (tHOAs) were examined. The unit of wavefront aberration is um.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To compare the corneal spherical component (SC), regular astigmatism (RA), irregular astigmatism (IA, including Asymmetry and Irregularity) and visual quality six years after small incision lenticule extraction (SMILE) and laser subepithelial keratomileusis (LASEK) for mild to moderate myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with mild to moderate myopia or myopic astigmatism who underwent SMILE or LASEK between October 2017 and May 2018 were enrolled', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) patients aged over 18 years; (2) absence of corneal, ocular, or systemic diseases; (3) stable refractive diopter maintained for the past 2 years with a change of ± 0.50 diopter; (4) discontinuation of soft contact lens wear for at least 2 weeks and rigid contact lenses for at least 4 weeks prior to surgery; (5) preoperative manifest refraction spherical equivalent (MRSE) less than -6.00 diopter (D)\n\nExclusion Criteria:\n\nA history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery'}, 'identificationModule': {'nctId': 'NCT06673992', 'acronym': 'SMILE LASEK', 'briefTitle': 'Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study', 'orgStudyIdInfo': {'id': 'Shanghai10HLi00001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'This study does not involve any interventions', 'type': 'OTHER', 'description': 'This study does not involve any interventions'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai 10th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Hua Li', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}