Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06216067
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2023-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diopters of Residual Cylinder', 'timeFrame': '1 Month postoperatively from implantation of intraocular lens', 'description': 'Diopters of Residual Cylinder at Month 1 with an upper boundary and lower boundary of +0.50 D and - 0.50 D'}], 'secondaryOutcomes': [{'measure': 'Accuracy of Residual Astigmatism (Predictive Error)', 'timeFrame': 'Month 1', 'description': 'Residual Astigmatism of +/- 0.25 D or less, +/- 0.75 D or less, +/- 1.00 or less'}, {'measure': 'Refractive predictability of the IOL (absolute difference between MRSE and target MRSE)', 'timeFrame': 'Month 1', 'description': 'MRSE within 0.25, 0.50, 0.75, 1.00 of target'}, {'measure': 'Uncorrected Distance Visual Acuities Achieved - Snellen', 'timeFrame': 'Month 1', 'description': 'Achievement of UCDVA of 20/20, 20/25, 20/30, 20/40 or better'}, {'measure': 'Procedure and Operating Room Time', 'timeFrame': 'Procedure time (up to 2 minutes)', 'description': 'Suction on (start of LenSx), treatment time of LenSx in seconds, Suction off (end of LenSx)'}, {'measure': 'Operating Room Time', 'timeFrame': 'Operating Room Time (up to 30 minutes)', 'description': 'Start and end time of matching reference image to microscope image, start time-primary incision, beginning of Phaco, end of Phaco, CDE (Combined Diffused Energy) Total, Start and end time of phakic power calculation, start and end time of toric positioning, end time of procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cataract', 'toric', 'cataract surgery', 'residual astigmatism'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism.\n\nThe main question it aims to answer is:\n\nShow the refractive predictability comparing the use of Operating Room cataract toric lens placement tools against the standard manual technique.\n\nParticipants will be implanted with the TECNIS Toric II IOL Lens Model ZCU; the second eye, if applicable, is to be implanted within 45 days of the first-eye surgery.\n\nResearchers will compare two Operating Room cataract lens placement tools: the Zeiss CALLISTO vs. the Wavetec AnalyzOR to determine refractive predictability.', 'detailedDescription': 'To evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism (maximum allowable up to 3.0D) comparing the ZEISS CALLISTO eye and the Wavetec AnalyzOR at the one-month post-operative visit. Both surgery rooms will be using Veracity, IOL Master and Zeiss Opmi Lumera i Operating Room Microscopes. Operating Room #1 will be utilizing the ZEISS CALLISTO eye for axis alignment, along with Veracity and IOL Master for lens selection, and Operating Room #2 will be utilizing the Wavetec AnalyzOR for lens selection and axis alignment. Procedure times for the ZEISS CALLISTO eye and the Wavetec AnalyzOR will be obtained by using a start/stop watch, including phakic power calculation and toric positioning. In addition, the suction on (start of LenSx), treatment time of LenSx in seconds, suction off (end of LenSx), start time of primary incision, the beginning of Phaco, end of phaco, CDE (Combined Diffused Energy) total and the end time of procedure will all be documented. All times will be analyzed and compared between Operating Room #1 and Operating Room #2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '87 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing unilateral or bilateral cataract extraction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral or bilateral cataract extraction with single piece hydrophobic acrylic posterior capsular intraocular lens correcting astigmatism.\n* Clear intraocular media other than cataract.\n* Willing and able to complete all required postoperative visits.\n* Able to comprehend and sign a statement of informed consent in English.\n\nExclusion Criteria:\n\n* Ocular disease or pathology that, in the opinion of the Investigator, will affect the post-operative visual acuity and manifest refraction.\n* Prior intraocular or corneal refractive surgery, corneal transplant, or retinal detachment.'}, 'identificationModule': {'nctId': 'NCT06216067', 'acronym': 'CORTCO', 'briefTitle': 'Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR', 'organization': {'class': 'OTHER', 'fullName': 'Chesapeake Eyecare and Laser Center, LLC'}, 'officialTitle': 'Comparison of Operating Room Toric Placement Tools, CALLISTO Eye vs. Wavetec AnalyzOR (CORTCO)', 'orgStudyIdInfo': {'id': 'MCS12112021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (Operating Room #1) CALLISTO eye', 'description': 'Group 1 (Operating Room #1) will have preoperative measurements with the IOL Master 700 and lens selection will be based on Veracity. The subjects in group 1 will have LenSx surgery and placement of the lens will be based on the CALLISTO eye.', 'interventionNames': ['Device: CALLISTO eye']}, {'label': 'Group 2 (Operating Room #2) Wavetec AnalyzOR', 'description': 'Group 2 (Operating Room #2) will also have preoperative measurements with the IOL Master700, but lens selection will be based on the Wavetec AnalyzOR. The subjects in group 2 will have LenSx surgery and placement of the lens will be based on the Wavetec AnalyzOR.', 'interventionNames': ['Device: Wavetec AnalyzOR']}], 'interventions': [{'name': 'CALLISTO eye', 'type': 'DEVICE', 'description': 'Cataract toric lens placement tool', 'armGroupLabels': ['Group 1 (Operating Room #1) CALLISTO eye']}, {'name': 'Wavetec AnalyzOR', 'type': 'DEVICE', 'description': 'Cataract toric lens placement tool', 'armGroupLabels': ['Group 2 (Operating Room #2) Wavetec AnalyzOR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Eye Care and Laser Center, LLC', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}], 'overallOfficials': [{'name': 'Maria C. Scott', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chesapeake Eyecare and Laser Center, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chesapeake Eyecare and Laser Center, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carl Zeiss Meditec, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Maria C. Scott, MD', 'investigatorFullName': 'Maria C. Scott', 'investigatorAffiliation': 'Chesapeake Eyecare and Laser Center, LLC'}}}}