Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05053620
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to treatment', 'timeFrame': '4 months after the procedure', 'description': 'Evaluation of the response to the procedure'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the visual acuity', 'timeFrame': '4 months after the procedure', 'description': 'Evaluation of the visual acuity'}, {'measure': 'Examination of the arcuate incisions', 'timeFrame': '4 months after the procedure', 'description': 'Examination of the arcuate incisions using a slit amp'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Cataract', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys femtosecond laser using the Cassini Ambient equipment with iris registration in cataract surgery.', 'detailedDescription': 'All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \\& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \\& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.\n\nA preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are already going to undergo conventional cataract surgery by phacoemulsification in which there is low corneal astigmatism (up to 1.25 D) and it is corrected by means of arcuate intrastromal incisions with femtosecond laser following routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are going to undergo cataract surgery.\n2. Low corneal astigmatism, between 0.50D and 1.25D.\n\nExclusion Criteria:\n\n1. Previous corneal surgery.\n2. Keratoconus.\n3. Corneal scars\n4. Pterygium\n5. Glaucoma'}, 'identificationModule': {'nctId': 'NCT05053620', 'acronym': 'ARCUATAS', 'briefTitle': 'Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'OFTALVIST (Oftalmología Vistahermosa S.L)'}, 'officialTitle': 'Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)', 'orgStudyIdInfo': {'id': 'ARCUATAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single arm', 'description': 'All patients.', 'interventionNames': ['Device: Calculation of the arcuate intrasomal incisions']}], 'interventions': [{'name': 'Calculation of the arcuate intrasomal incisions', 'type': 'DEVICE', 'description': 'All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \\& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \\& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03015', 'city': 'Alicante', 'country': 'Spain', 'facility': 'OFTALVIST (Oftalmología Vistahermosa S.L.)', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'overallOfficials': [{'name': 'Pedro Tañá Rivero, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OFTALVIST (Oftalmología Vistahermosa S.L)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OFTALVIST (Oftalmología Vistahermosa S.L)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson Surgical Vision, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}