Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01278420
Status:
UNKNOWN
Last Update Posted:
2012-06-14
First Post:
2010-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refraction', 'timeFrame': '1 year'}, {'measure': 'Distance Visual Acuities', 'timeFrame': '1 year'}, {'measure': 'Near Visual Acuities', 'timeFrame': '1 year'}, {'measure': 'Intermediate Acuities', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.', 'detailedDescription': 'The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or greater\n* Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes\n* Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation\n* Clear intraocular media other than cataract\n* Normal OCT of the macula\n* No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography\n* No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam\n* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures\n\nExclusion Criteria:\n\n* Use of systemic or ocular medications that may affect vision\n* Uncontrolled systemic or ocular disease\n* History of ocular trauma\n* History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)\n* Amblyopia or strabismus\n* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)\n* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse\n* Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)\n* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)\n* Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses'}, 'identificationModule': {'nctId': 'NCT01278420', 'briefTitle': "AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL", 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': "AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL", 'orgStudyIdInfo': {'id': 'TMF vs Restor MF 3D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tecnis MF', 'interventionNames': ['Device: Tecnis MF']}, {'type': 'OTHER', 'label': 'ReSTOR', 'interventionNames': ['Device: ReSTOR']}], 'interventions': [{'name': 'Tecnis MF', 'type': 'DEVICE', 'description': '30 subjects will be implanted with the Tecnis MF', 'armGroupLabels': ['Tecnis MF']}, {'name': 'ReSTOR', 'type': 'DEVICE', 'description': '30 subjects will be implanted with ReSTOR', 'armGroupLabels': ['ReSTOR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93101', 'city': 'Santa Barbara', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sansum- Santa Barbara medical foundation Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry Katzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Katzen Eye Care & Laser Center', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Trattler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60046', 'city': 'Lake Villa', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitch Jackson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jackson Eye, SC', 'geoPoint': {'lat': 42.41697, 'lon': -88.07397}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Waltz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eye Surgeons of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '44141', 'city': 'Breckville', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shamik Bafna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Eye Clinic'}], 'centralContacts': [{'name': 'Jenna Piel', 'role': 'CONTACT', 'email': 'j.piel@imedsonline.com', 'phone': '951-653-5566'}], 'overallOfficials': [{'name': 'William Trattler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Excellence in Eye Care'}, {'name': 'Mitch Jackson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jackson Eye'}, {'name': 'Larry Katzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Katzen Eye Care & Laser Center'}, {'name': 'Kevin Waltz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Surgeons of Indiana'}, {'name': 'Shamik Bafna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clevland Eye Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'William Trattler', 'oldOrganization': 'The Center for Excellence in Eye Care'}}}}