Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-29 @ 5:31 AM
Study NCT ID:
NCT00999492
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2009-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront
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': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of spectacle wear', 'timeFrame': '3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Frequency and degree of visual symptoms', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tecnis Multifocal', 'Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses'], 'conditions': ['Cataracts']}, 'descriptionModule': {'briefSummary': 'Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled to undergo bilateral cataract or refractive lens surgery\n* Visual potential of 20/30 or better in each eye after lens removal and IOL implantation\n* Naturally dilated pupil size (in dim light) \\> 3.5 mm (with no dilation medications) for both eyes\n* Preoperative regular corneal astigmatism of 2.5 D or less\n* Clear intraocular media other than cataract\n* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures\n\nExclusion Criteria:\n\n* Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.\n* Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)\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 or prior ocular surgery\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)\n* Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses\n* Requiring an intraocular lens power \\<15.0 or \\>26.0 diopters'}, 'identificationModule': {'nctId': 'NCT00999492', 'briefTitle': 'Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront', 'nctIdAliases': ['NCT01061892'], 'organization': {'class': 'OTHER', 'fullName': 'Drs. Fine, Hoffman and Packer, LLC'}, 'officialTitle': 'Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront', 'orgStudyIdInfo': {'id': 'TMF-09-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tecnis® Multifocal (TMF)', 'type': 'DEVICE', 'description': 'Aspheric, diffractive multifocal intraocular lenses'}]}, '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark Packer, MD, FACS', 'class': 'OTHER'}, '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'}}}}