Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT01713660
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corneal Incisions With the IntraLase iFS Femtosecond Laser System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carrie.garufis@amo.abbott.com', 'phone': '7145663728', 'title': 'Carrie Garufis', 'organization': 'AMO'}, 'certainAgreement': {'otherDetails': 'Clinical Trial Agreement including "Neither Institution nor Principal Investigator shall have any right to publish or present any information or results concerning the Study without express written consent of Sponsor. Under no circumstances shall Institution or Principal Investigator publish or disclose any of Sponsor\'s proprietary information, as defined by the CDAs, without Sponsor\'s prior written approval."', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The time frame for reporting adverse event reports was 1 month.', 'eventGroups': [{'id': 'EG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser'}], 'classes': [{'title': 'Achieved Clear Corneal Incision (CCI) Measurement', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Intended CCI Incision Size (as programmed)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Operative (Within 2 hours of incision creation)', 'description': 'Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Surgeon Assessment of Workflow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0, Operative', 'description': 'Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?', 'unitOfMeasure': 'percentage of yes answers', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Seidel Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (performed immediately post-incision creation), Day 1', 'description': 'Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.', 'unitOfMeasure': 'percentage of eyes with negative Seidel', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from private medical practices from October to December 2012', 'preAssignmentDetails': 'No preassignment details'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FS Corneal Incisions', 'description': 'iFS Femtosecond Laser : corneal incisions created by the femtosecond laser'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2012-10-22', 'resultsFirstSubmitDate': '2013-04-05', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-04-05', 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.', 'timeFrame': 'Day 0, Operative (Within 2 hours of incision creation)', 'description': 'Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).'}], 'secondaryOutcomes': [{'measure': 'Surgeon Assessment of Workflow', 'timeFrame': 'Day 0, Operative', 'description': 'Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?'}, {'measure': 'Percent of Seidel Staining', 'timeFrame': 'Day 0 (performed immediately post-incision creation), Day 1', 'description': 'Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract surgery', 'Femtosecond laser', 'Corneal incisions'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 21 years of age\n* Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned\n* Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation\n* Clear intraocular media other than cataract\n* Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)\n* History of active or recurrent ophthalmic disease\n* Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)\n* White to white measurement less than 10 mm or greater than 14 mm\n* Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation\n* Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study\n* Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study\n* Subjects with conditions associated with increased risk of IOL/capsule instability\n* Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities\n* Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)\n* History of any ocular or medical conditions that could affect corneal wound healing\n* Poorly-controlled diabetes or subjects with diabetic retinopathy\n* Concurrent use of topical or systemic medications that may impair corneal wound healing\n* Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)\n* Ocular hypertension (\\> 21 mm Hg)\n* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study\n* Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course\n* Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit'}, 'identificationModule': {'nctId': 'NCT01713660', 'briefTitle': 'Corneal Incisions With the IntraLase iFS Femtosecond Laser System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY', 'orgStudyIdInfo': {'id': 'FMTO-105-CCIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FS Corneal Incisions', 'interventionNames': ['Device: iFS Femtosecond Laser']}], 'interventions': [{'name': 'iFS Femtosecond Laser', 'type': 'DEVICE', 'description': 'corneal incisions created by the femtosecond laser', 'armGroupLabels': ['FS Corneal Incisions']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}