Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01014702
Status:
UNKNOWN
Last Update Posted:
2011-04-15
First Post:
2009-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Clinical Trial of the LensAR Laser System
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-14', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completeness and ease of opening of capsulotomy', 'timeFrame': 'Day 0 (Surgery)'}, {'measure': 'Reduced need for ultrasound phacoemulsification compared to control eye', 'timeFrame': 'Day 0 (surgery)'}, {'measure': 'Rate of adverse events', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract', 'Capsulotomy', 'Capsulorrhexis', 'lens fragmentation', 'phacoemulsification'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must sign and be given a copy of the written informed consent form\n* Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.\n* Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.\n* Subjects must have central 7 mm of clear cornea without vascularization.\n\nExclusion Criteria:\n\n* Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.\n* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.\n* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.\n* Subjects with macular degenerative pathology.\n* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.\n* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.\n* Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light."}, 'identificationModule': {'nctId': 'NCT01014702', 'briefTitle': 'Prospective Clinical Trial of the LensAR Laser System', 'organization': {'class': 'INDUSTRY', 'fullName': 'LensAR Incorporated'}, 'officialTitle': 'Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity', 'orgStudyIdInfo': {'id': '52-00006-000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Treatment', 'interventionNames': ['Device: LensAR Laser System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phacoemulsifcation', 'interventionNames': ['Device: Conventional phacoemulsification']}], 'interventions': [{'name': 'LensAR Laser System', 'type': 'DEVICE', 'description': 'Use of laser for capsulotomy and lens fragmentation', 'armGroupLabels': ['Laser Treatment']}, {'name': 'Conventional phacoemulsification', 'type': 'DEVICE', 'description': 'Use of standard techniques for capsulotomy and lens fragmentation', 'armGroupLabels': ['Phacoemulsifcation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociacion para Evitar la Ceguera en Mexico IAP', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LensAR Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Keith Edwards, Director Clinical & Regulatory Affairs', 'oldOrganization': 'LensAR Incorporated'}}}}