Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 1:37 PM
Study NCT ID:
NCT00742950
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2008-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refractive Change Induced by 2.8-mm Corneal Incision
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induced corneal refractive change', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'ISV change', 'timeFrame': '6 months'}, {'measure': 'Visual acuity', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Corneal incision', 'Cataract surgery', 'Phacoemulsification', 'Surgically induced astigmatism', 'Corneal Topography'], 'conditions': ['Cataract', 'Refractive Surgery', 'Astigmatism']}, 'referencesModule': {'references': [{'pmid': '15860279', 'type': 'BACKGROUND', 'citation': 'Tejedor J, Murube J. Choosing the location of corneal incision based on preexisting astigmatism in phacoemulsification. Am J Ophthalmol. 2005 May;139(5):767-76. doi: 10.1016/j.ajo.2004.12.057.'}, {'pmid': '19011013', 'type': 'DERIVED', 'citation': 'Tejedor J, Perez-Rodriguez JA. Astigmatic change induced by 2.8-mm corneal incisions for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):989-94. doi: 10.1167/iovs.08-2778. Epub 2008 Nov 14.'}]}, 'descriptionModule': {'briefSummary': "The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.\n\nPatients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.\n\nOutcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual impairment for daily tasks caused by cataract\n* Age older than 50 years\n* Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°\n* Ability to cooperate in the protocol procedures\n\nExclusion Criteria:\n\n* Age below 50\n* Inability to cooperate with measurements'}, 'identificationModule': {'nctId': 'NCT00742950', 'acronym': 'CINPHA', 'briefTitle': 'Refractive Change Induced by 2.8-mm Corneal Incision', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery', 'orgStudyIdInfo': {'id': 'CINPHACO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Nasal 2.8-mm corneal incision', 'interventionNames': ['Procedure: Nasal 2.8-mm corneal incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Temporal 2.8-mm corneal incision', 'interventionNames': ['Procedure: Temporal 2.8-mm corneal incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'III', 'description': 'Superior 2.8-mm corneal incision', 'interventionNames': ['Procedure: Superior 2.8-mm incision']}], 'interventions': [{'name': 'Nasal 2.8-mm corneal incision', 'type': 'PROCEDURE', 'otherNames': ['Phacoemulsification nasal incision'], 'description': 'Phacoemulsification through a nasal 2.8-mm incision', 'armGroupLabels': ['I']}, {'name': 'Temporal 2.8-mm corneal incision', 'type': 'PROCEDURE', 'otherNames': ['Phacoemulsification temporal incision'], 'description': 'Phacoemulsification through a 2.8-mm temporal incision', 'armGroupLabels': ['II']}, {'name': 'Superior 2.8-mm incision', 'type': 'PROCEDURE', 'otherNames': ['Phacoemulsification superior incision'], 'description': 'Phacoemulsification through a superior 2.8-mm corneal incision', 'armGroupLabels': ['III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Dept Ophthalmology, Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jaime Tejedor, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Ophthalmology'}, {'name': 'José A Pérez-Rodríguez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jaime Tejedor / Dr', 'oldOrganization': 'Hospital Ramón y Cajal'}}}}