Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT01275118
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-20', 'releaseDate': '2014-08-04'}, {'resetDate': '2014-09-05', 'releaseDate': '2014-08-28'}], 'estimatedResultsFirstSubmitDate': '2014-08-04'}}, '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': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual function', 'timeFrame': '3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Use of spectacle correction and vision-related quality of life', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL\n* Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye\n* Naturally dilated pupil size (in dim light) \\> 3.5 mm (with no dilation medications) for both eyes\n* Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)\n* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures\n\nExclusion Criteria:\n\n* Ocular disease which could potentially limit uncorrected visual acuity or visual performance.\n* Use of systemic or ocular medications that may affect visual outcomes\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)\n* Uncontrolled systemic or ocular disease\n* History of ocular trauma\n* History of ocular surgery other than that required for inclusion in this study\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 worse than 20/30\n* Subjects who may be expected to require retinal laser treatment or other surgical intervention\n* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)\n* Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)'}, 'identificationModule': {'nctId': 'NCT01275118', 'briefTitle': 'Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL', 'organization': {'class': 'OTHER', 'fullName': 'Drs. Fine, Hoffman and Packer, LLC'}, 'officialTitle': 'Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence With Bilateral Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens AO (CAO) Intraocular Lens', 'orgStudyIdInfo': {'id': 'TMF-09-002 Rev.5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tecnis Multifocal IOL', 'type': 'DEVICE', 'description': 'Presbyopia correcting IOL'}, {'name': 'crystalens Accommodating IOL', 'type': 'DEVICE', 'description': 'Presbyopia correcting IOL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Drs. Fine, Hoffman and Packer, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Mark Packer, MD, FACS, CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drs. Fine, Hoffman and Packer, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark Packer, MD, FACS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Mark Packer, MD, FACS', 'investigatorAffiliation': 'Drs. Fine, Hoffman and Packer, LLC'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-08-04', 'type': 'RELEASE'}, {'date': '2014-08-20', 'type': 'RESET'}, {'date': '2014-08-28', 'type': 'RELEASE'}, {'date': '2014-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mark Packer, MD, FACS, Sponsor-Investigator, Drs. Fine, Hoffman and Packer, LLC'}}}}