Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-02 @ 12:08 PM
Study NCT ID:
NCT02304861
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2014-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss
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': 'C501944', 'term': 'chondroitin sulfate, sodium hyaluronate drug combination'}, {'id': 'C561626', 'term': 'visthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-14', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Cell Count (ECD)', 'timeFrame': '3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Endothelial Cell pattern (ECP)', 'timeFrame': '3 months postoperatively'}, {'measure': 'Central corneal edema (CCE)', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cataract', 'viscoelastic (OVD) technology', 'endothelial cell count', 'endothelial cell pattern', 'central corneal edema'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '25804586', 'type': 'RESULT', 'citation': 'Labiris G, Sideroudi H, Rousopoulos K, Kozobolis VP. Cohesive versus dispersive-cohesive ophthalmic viscosurgical device in torsional intelligent phaco. J Cataract Refract Surg. 2015 Mar;41(3):681-2. doi: 10.1016/j.jcrs.2015.01.010. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Objective of this study is the comparative assessment of the beneficial impact of the Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following torsional-ip cataract extraction surgery.\n\nParticipants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer randomization program all participants will randomly populate two study groups according to the OVD used (ie. viscoat or visthesia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of senile cataract with stage 3 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': 'NCT02304861', 'briefTitle': 'Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss', 'orgStudyIdInfo': {'id': 'visco07012eit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Viscoat group', 'description': 'Patients operated using Viscoat OVD', 'interventionNames': ['Procedure: Viscoat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Visthesia group', 'description': 'Patients operated using Visthesia OVD', 'interventionNames': ['Procedure: Visthesia']}], 'interventions': [{'name': 'Viscoat', 'type': 'PROCEDURE', 'description': "Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision 3% Sodium Hyaluronate, 4% Chondroitin Sulfate (Viscoat, Alcon, Greece) was injected in the anterior chamber", 'armGroupLabels': ['Viscoat group']}, {'name': 'Visthesia', 'type': 'PROCEDURE', 'description': "Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision sodium hyaluronate 1.5% and lidocaine hydrochloride 1% ophthalmic viscosurgical device (OVD) (Visthesia, Carl Zeiss, Germany) was injected in the anterior chamber", 'armGroupLabels': ['Visthesia 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': 'Assistant Professor', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}