Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-01 @ 2:52 PM
Study NCT ID:
NCT01480557
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011545', 'term': 'semen liquefaction factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-14', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial cell count (ECC)', 'timeFrame': '1 month postoperatively'}], 'secondaryOutcomes': [{'measure': 'Uncorrected visual acuity (UVA)', 'timeFrame': '1 month postoperatively'}, {'measure': 'Central corneal thickness (CCT)', 'timeFrame': '1 month postoperatively'}, {'measure': 'Central Corneal Sensitivity (CCS)', 'timeFrame': '1 month postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract', 'phacoemulsification', 'liquefaction', 'torsional ip', 'endothelial cell count', 'central corneal edema', 'central corneal sensitivity'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '23095606', 'type': 'RESULT', 'citation': 'Labiris G, Gatzioufas Z, Giarmoukakis A, Sideroudi H, Kozobolis VP. Liquefaction versus torsional IP: a comparative study on endothelial cells, corneal edema and corneal sensitivity. Ophthalmic Res. 2013;49(1):37-42. doi: 10.1159/000342974. Epub 2012 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.\n\nParticipants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale \\[10\\]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale\n\nExclusion Criteria:\n\n* Endothelial cell count less than 1900,\n* glaucoma,\n* IOP-lowering medications,\n* former incisional surgery,\n* former diagnosis of corneal disease,\n* diabetes or autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT01480557', 'briefTitle': 'Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity', 'orgStudyIdInfo': {'id': 'liq75tor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liquefaction group', 'description': 'Subjects that were operated for cataract using liquefaction technology', 'interventionNames': ['Procedure: liquefaction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Torsional ip group', 'description': 'Subjects that were operated for cataract using torsional ip technology', 'interventionNames': ['Procedure: Torsional ip']}], 'interventions': [{'name': 'liquefaction', 'type': 'PROCEDURE', 'description': 'Cataract extraction surgery type', 'armGroupLabels': ['Liquefaction group']}, {'name': 'Torsional ip', 'type': 'PROCEDURE', 'description': 'A type cataract surgery using torsional ip technology', 'armGroupLabels': ['Torsional ip group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'University Hospital of Alexandroupolis', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Democritus University of Thrace'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}