Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 6:16 AM
Study NCT ID:
NCT01383057
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2011-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
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': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-15', 'studyFirstSubmitDate': '2011-06-24', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '3 months', 'description': 'Measure the fluid pressure inside the eye'}, {'measure': 'Uncorrected and Best corrected Visual Acuity', 'timeFrame': 'one month', 'description': 'Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataracts']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.\n* Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.\n\n * The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.\n\nExclusion Criteria:\n\n* Concurrent participation or participation in the last thirty days in any other clinical trial.\n* Known steroid IOP responder\n* Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)\n* Uncontrolled systemic or ocular disease\n* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)\n* Pseudoexfoliation\n* Ocular hypertension IOP \\>25 mmHg by tonometry or glaucomatous changes in the optic nerve"}, 'identificationModule': {'nctId': 'NCT01383057', 'briefTitle': 'Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery', 'orgStudyIdInfo': {'id': 'FEMTO 2011-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Femtosecond Laser', 'interventionNames': ['Procedure: Femtosecond Laser']}], 'interventions': [{'name': 'Femtosecond Laser', 'type': 'PROCEDURE', 'description': 'Using the Femtosecond Laser to make a clear corneal incision.', 'armGroupLabels': ['Femtosecond Laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Loden Vision Centers', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}