Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-28 @ 4:38 PM
Study NCT ID:
NCT04110067
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2019-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High 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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Distance Refraction', 'timeFrame': '1 year', 'description': 'Subjective Refraction'}, {'measure': 'Distance Visual Acuity', 'timeFrame': '1 year', 'description': 'Visual Acuity sine and cum correctione'}], 'secondaryOutcomes': [{'measure': 'Tectonic stability as assessed by Pentacam', 'timeFrame': '1 year', 'description': 'Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography'}, {'measure': 'Epithelial thickness map in Optical coherence tomography', 'timeFrame': '1 year', 'description': 'Change of Thickness of epithelium pre and post surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Myopia', 'Refractive Surgery', 'Small Incision Lenticule Extraction', 'SMILE'], 'conditions': ['Myopia', 'High Myopia']}, 'descriptionModule': {'briefSummary': 'Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.\n\nIt involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.\n\nThis observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.\n\nIt is to\n\n* gather long-term results and refractive stability\n* detect rare complications or side-effects\n* evaluate the efficacy in a large number of patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with myopia more than -7.75 D seeking refractive surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* myopia more than -7.75 D\n* refractive stability more than 1 year\n\nExclusion Criteria:\n\n* corneal irregular astigmatism\n* ectatic conditions'}, 'identificationModule': {'nctId': 'NCT04110067', 'briefTitle': 'Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia', 'organization': {'class': 'OTHER', 'fullName': 'St. Franziskus Hospital'}, 'officialTitle': 'Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia', 'orgStudyIdInfo': {'id': 'SMILE > 7.75D'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'SMILE - Correction of eyes with myopia of more than -7.75 D', 'interventionNames': ['Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)']}], 'interventions': [{'name': 'Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)', 'type': 'OTHER', 'otherNames': ['RelaxSmile'], 'description': 'Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48145', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Suphi Taneri, MD', 'role': 'CONTACT', 'email': 'taneri@refraktives-zentrum.de', 'phone': '+492519877890'}], 'facility': 'Center for Refractive Surgery', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Suphi Taneri, MD', 'role': 'CONTACT', 'email': 'taneri@refraktives-zentrum.de', 'phone': '+492519877890'}, {'name': 'Anika Förster, M.Sc.', 'role': 'CONTACT', 'email': 'foerster@refraktives-zentrum.de', 'phone': '+492519877890'}], 'overallOfficials': [{'name': 'Suphi Taneri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Refractive Surgery Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suphi Taneri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Suphi Taneri', 'investigatorAffiliation': 'St. Franziskus Hospital'}}}}