Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-01 @ 3:29 AM
Study NCT ID:
NCT01088568
Status:
UNKNOWN
Last Update Posted:
2010-03-17
First Post:
2010-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-05-03', 'releaseDate': '2011-04-07'}], 'estimatedResultsFirstSubmitDate': '2011-04-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-16', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK', 'timeFrame': '1week, 1,3,6 months'}], 'secondaryOutcomes': [{'measure': 'Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK', 'timeFrame': '1, 3, 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keratomileusis, laser in situ', 'Phakic Intraocular Lenses', 'myopia', 'astigmatism', 'Implantable Collamer Lens, Toric'], 'conditions': ['Myopia', 'Astigmatism']}, 'referencesModule': {'references': [{'pmid': '17598571', 'type': 'BACKGROUND', 'citation': 'Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.'}, {'pmid': '17172886', 'type': 'BACKGROUND', 'citation': 'Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.'}, {'pmid': '12792475', 'type': 'BACKGROUND', 'citation': 'Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 21-45 years old\n* Documented stable refraction for at least 1 year\n* (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D\n* BSCVA: 20/20 or better\n* Pupil diameter: smaller than 7mm under mesopic condition\n* Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively\n\nExclusion Criteria:\n\n* Evidence of progressive or acute disease\n* Evidence of connective tissue disease or clinically significant atopic disease\n* ACD less than 2.8mm from endothelium\n* ECC less than 2200 cells/mm2\n* Narrow angle of anterior chamber\n* Residual stromal thickness less than 280 microns'}, 'identificationModule': {'nctId': 'NCT01088568', 'briefTitle': 'Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism', 'orgStudyIdInfo': {'id': '20091231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TICL group', 'interventionNames': ['Procedure: the implantation of toric implantable collamer lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LASIK group', 'interventionNames': ['Procedure: customized laser-assisted in situ keratomileusis']}], 'interventions': [{'name': 'the implantation of toric implantable collamer lens', 'type': 'PROCEDURE', 'otherNames': ['TICL'], 'description': 'perform the implantation of toric implantable collamer lens for both eyes', 'armGroupLabels': ['TICL group']}, {'name': 'customized laser-assisted in situ keratomileusis', 'type': 'PROCEDURE', 'otherNames': ['Q-factor customized LASIK'], 'description': 'perform Q-factor customized laser-assisted in situ keratomileusis for both eyes', 'armGroupLabels': ['LASIK group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Qin Mei Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eye hospital of Wenzhou Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Staar Surgical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Qinmei Wang MD', 'oldOrganization': 'Eye hospital of Wenzhou Medical College'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-04-07', 'type': 'RELEASE'}, {'date': '2011-05-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eye hospital of Wenzhou Medical College (Qinmei Wang MD)'}}}}