Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06788418
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision at 12 months post-surgery', 'timeFrame': 'From the day of surgery through to the 12-month post-operative follow-up', 'description': 'Uncorrected distance vision (UDVA) at 12 months post-surgery'}], 'secondaryOutcomes': [{'measure': 'Change in spherical equivalent at 12 months post-surgery', 'timeFrame': 'From the day of surgery through to the 12-month post-operative follow-up', 'description': 'Change of the spherical equivalent at 12 months post-surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia', 'Small Incision Lenticule Extraction', 'Implantable Collamer Lens', 'Wavelight Plus Alcon system', 'vision'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '39774960', 'type': 'BACKGROUND', 'citation': 'Meng ZY, Yang L, Zhou P. Femtosecond laser versus manual clear corneal incision in implantable collamer lens surgery. Sci Rep. 2025 Jan 7;15(1):1086. doi: 10.1038/s41598-024-81477-w.'}]}, 'descriptionModule': {'briefSummary': 'Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-40 years\n* Spherical equivalent of -1.00 to -10.00 D\n* Stable refraction for at least 12 months\n* Informed consent provided\n\nExclusion Criteria:\n\n* Other ocular pathologies\n* Previous refractive surgery\n* Pregnancy or nursing\n* Autoimmune or connective tissue disorders'}, 'identificationModule': {'nctId': 'NCT06788418', 'briefTitle': 'Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Visionly Plus Eye Hospital'}, 'officialTitle': 'Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction', 'orgStudyIdInfo': {'id': 'Himalaya202501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMILE Group', 'description': 'Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser', 'interventionNames': ['Procedure: SMILE']}, {'type': 'EXPERIMENTAL', 'label': 'ICL group', 'description': 'Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL', 'interventionNames': ['Procedure: ICL']}, {'type': 'EXPERIMENTAL', 'label': 'Wavelight Plus Alcon Group', 'description': 'Laser vision correction using the Wavelight Plus Alcon system', 'interventionNames': ['Procedure: Wavelight Plus Alcon system']}], 'interventions': [{'name': 'Wavelight Plus Alcon system', 'type': 'PROCEDURE', 'otherNames': ['Small Incision Lenticule Extraction', 'Implantable Collamer Lens'], 'description': 'Wavelight Plus Alcon system guided surgery for myopia', 'armGroupLabels': ['Wavelight Plus Alcon Group']}, {'name': 'SMILE', 'type': 'PROCEDURE', 'description': 'Small Incision Lenticule Extraction surgery for myopia', 'armGroupLabels': ['SMILE Group']}, {'name': 'ICL', 'type': 'PROCEDURE', 'description': 'Implantable Collamer Lens surgery for myopia', 'armGroupLabels': ['ICL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Yang, M.D.', 'role': 'CONTACT', 'email': 'roc001cn@gmail.com', 'phone': '+86-17898805125'}], 'facility': 'Beijing New Vision Eye Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100027', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Visionly Plus Eye Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Peng ZHOU, M.D.', 'role': 'CONTACT', 'email': 'drzhoupeng@gmail.com', 'phone': '+86-18801871108'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'January 2025-January 2027', 'ipdSharing': 'YES', 'description': 'Only IPD used in the results publication will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Visionly Plus Eye Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'High Myopia Control Alliance (HIMALAYA)', 'class': 'UNKNOWN'}, {'name': 'Beijing New Vision Eye Hospital', 'class': 'UNKNOWN'}, {'name': 'Shanghai Parkway Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}