Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Primary Purpose
Eye Infections
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Povidone-iodine
Saline Solution
Sponsored by
About this trial
This is an interventional prevention trial for Eye Infections focused on measuring Povidone-Iodine, Ophthalmic Solutions, Endophthalmitis, Preoperative procedures
Eligibility Criteria
Inclusion Criteria:
- No systemic or ocular infection;
- Absence of auto-imune disease or immunosuppressive therapy;
- No use of systemic or topic antibiotics in the last 30 days;
- No previous ocular surgery or trauma in the study eye in the last 30 days;
- No history of allergy to povidone iodine;
- Signed informed consent.
Exclusion Criteria:
- Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;
- Diabetes Mellitus;
- Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;
- Inability to understand and sign the informed consent.
Sites / Locations
- Clinics Hospital of Ribeirão Preto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Povidone-iodine
Povidone-iodine and Saline Solution
Arm Description
1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
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%.
Outcomes
Primary Outcome Measures
Proportion of negative cultures after treatment in both groups
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).
Secondary Outcome Measures
Difference in corneal thickness change between groups.
Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Full Information
NCT ID
NCT01739920
First Posted
November 28, 2012
Last Updated
January 23, 2017
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01739920
Brief Title
Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Official Title
Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections
Keywords
Povidone-Iodine, Ophthalmic Solutions, Endophthalmitis, Preoperative procedures
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Povidone-iodine
Arm Type
Experimental
Arm Description
1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
Arm Title
Povidone-iodine and Saline Solution
Arm Type
Active Comparator
Arm 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%.
Intervention Type
Other
Intervention Name(s)
Povidone-iodine
Intervention Description
Povidone iodine 5% drop will be instilled into conjunctival sac.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
1 drop of saline solution 0.9% will be instilled into conjunctival sac.
Primary Outcome Measure Information:
Title
Proportion of negative cultures after treatment in both groups
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).
Time Frame
At 30-minute study period, a conjunctival sac swab will be obtained
Secondary Outcome Measure Information:
Title
Difference in corneal thickness change between groups.
Description
Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Time Frame
At 35-minute study period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No systemic or ocular infection;
Absence of auto-imune disease or immunosuppressive therapy;
No use of systemic or topic antibiotics in the last 30 days;
No previous ocular surgery or trauma in the study eye in the last 30 days;
No history of allergy to povidone iodine;
Signed informed consent.
Exclusion Criteria:
Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;
Diabetes Mellitus;
Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;
Inability to understand and sign the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Jorge, MD, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leticia F Barroso, MD
Organizational Affiliation
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
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