Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT01739920
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D009877', 'term': 'Endophthalmitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of negative cultures after treatment in both groups', 'timeFrame': 'At 30-minute study period, a conjunctival sac swab will be obtained', 'description': 'Conjunctival swab will be obtained five minutes before and 30 minutes after the first povidone iodine drop will be instilled into the conjunctival sac of study eye. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (Agar Chocolate, Trypticase Soy Agar with 5% sheep blood, and Agar Sabouraud).'}], 'secondaryOutcomes': [{'measure': 'Difference in corneal thickness change between groups.', 'timeFrame': 'At 35-minute study period.', 'description': 'Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Povidone-Iodine', 'Ophthalmic Solutions', 'Endophthalmitis', 'Preoperative procedures'], 'conditions': ['Eye Infections']}, 'descriptionModule': {'briefSummary': 'The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.', 'detailedDescription': 'Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No systemic or ocular infection;\n* Absence of auto-imune disease or immunosuppressive therapy;\n* No use of systemic or topic antibiotics in the last 30 days;\n* No previous ocular surgery or trauma in the study eye in the last 30 days;\n* No history of allergy to povidone iodine;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;\n* Diabetes Mellitus;\n* Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;\n* Inability to understand and sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT01739920', 'briefTitle': 'Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora', 'orgStudyIdInfo': {'id': '2516/2010'}, 'secondaryIdInfos': [{'id': '2010/17350-6', 'type': 'OTHER_GRANT', 'domain': 'Fundação de Amparo à Pesquisa do Estado de São Paulo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone-iodine', 'description': '1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.', 'interventionNames': ['Other: Povidone-iodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone-iodine and Saline Solution', 'description': '1 drop of saline solution 0.9% will be instilled at time zero and 20-minute. At 28-minute will be instilled 1 drop of Povidone-iodine 5%.', 'interventionNames': ['Other: Povidone-iodine', 'Other: Saline Solution']}], 'interventions': [{'name': 'Povidone-iodine', 'type': 'OTHER', 'description': 'Povidone iodine 5% drop will be instilled into conjunctival sac.', 'armGroupLabels': ['Povidone-iodine', 'Povidone-iodine and Saline Solution']}, {'name': 'Saline Solution', 'type': 'OTHER', 'description': '1 drop of saline solution 0.9% will be instilled into conjunctival sac.', 'armGroupLabels': ['Povidone-iodine and Saline Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinics Hospital of Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Rodrigo Jorge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Leticia F Barroso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Leticia Fernandes Barroso', 'investigatorAffiliation': 'University of Sao Paulo'}}}}