Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06710951
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients did not know which percentage of povidone-iodine was utilized during their injection.\n\nTear breaking time and bulbar redness were automized results by Keraatopgrah. Oxford scale pre and post injection was staged by an investigator that did not know the group in which the patient was.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear breaking rupture', 'timeFrame': 'Change from baseline measured to 15 minutes post-injection', 'description': 'NIKBUT was measured with Keratopgraph before and after intravitreal injection'}, {'measure': 'Bulbar redness', 'timeFrame': 'Change from baseline measured to 15 minutes post-injection', 'description': 'Bulbar redness was measured with Keratopgraph before and after intravitreal injection'}], 'secondaryOutcomes': [{'measure': 'Oxford scale', 'timeFrame': 'Change from baseline measured to 15 minutes post-injection', 'description': 'Oxford scale was measured with fluorescein stain before and after intravitreal injection'}, {'measure': 'Pain analog scale', 'timeFrame': 'Change from baseline measured to 15 minutes post-injection', 'description': 'Pain using visual analog scale was measured 15 minutes and 48 hours after intravitreal injection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Povidone-iodine', 'Pain'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection', 'detailedDescription': 'Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Having anti-VGEF intravitreal injection scheduled\n* Informed consent signed\n\nExclusion Criteria\n\n* Under 45 years\n* Opacity that prevents ophthalmological evaluation and fixation\n* Patients with severe dry eye\n* Patients with signs of infection on the ocular surface\n* Allergy to iodine\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06710951', 'acronym': 'anti-VEGF', 'briefTitle': 'Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections', 'orgStudyIdInfo': {'id': 'RE-21-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone-iodine 1%', 'description': 'Povidone-iodine 1% was used as antiseptic during anti-VEGF intravitreal injection', 'interventionNames': ['Procedure: Change of normal concentration of povidone-iodine 5% to 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone-iodine 5%', 'description': 'Povidone-iodine 5% was used as antiseptic during anti-VEGF intravitreal injection', 'interventionNames': ['Procedure: Change of normal concentration of povidone-iodine 5% to 1%']}], 'interventions': [{'name': 'Change of normal concentration of povidone-iodine 5% to 1%', 'type': 'PROCEDURE', 'description': 'Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.', 'armGroupLabels': ['Povidone-iodine 1%', 'Povidone-iodine 5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México I.A.P.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'José Gerardo García-Aguirre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México I.A.P.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'José Gerardo García Aguirre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Retina Adjunct', 'investigatorFullName': 'José Gerardo García Aguirre', 'investigatorAffiliation': 'Asociación para Evitar la Ceguera en México'}}}}