Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01061918
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2010-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
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'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refraction', 'timeFrame': '1 year'}, {'measure': 'Distance Visual Acuities', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 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 intraocular lenses (IOLs) 6 months post cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or greater\n* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes\n* Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation\n* Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40\n* Naturally dilated pupil size (in dim light) \\> 3.5 mm (with no dilation medications) for both eyes\n* Preoperative corneal astigmatism of 1.0 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* Use of systemic or ocular medications that may affect vision\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)\n* Subjects with diabetes mellitus\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 20/30 or worse\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, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)\n* Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses\n* Requiring an intraocular lens \\<15.0 or \\>26.0 diopters'}, 'identificationModule': {'nctId': 'NCT01061918', 'briefTitle': 'Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses', 'orgStudyIdInfo': {'id': 'Tecnis MF/Restor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tecnis MF', 'interventionNames': ['Device: Tecnis MF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ReSTOR', 'interventionNames': ['Device: ReSTOR']}], 'interventions': [{'name': 'Tecnis MF', 'type': 'DEVICE', 'description': '20 patients in the Tecnis MF group.', 'armGroupLabels': ['Tecnis MF']}, {'name': 'ReSTOR', 'type': 'DEVICE', 'description': '20 patients in the ReSTOR group.', 'armGroupLabels': ['ReSTOR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'William Trattler', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'William Lahners', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'William Lahners', 'oldOrganization': 'Center For Sight'}}}}