NCT01739920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

3.4 years

First QC Date

November 28, 2012

Last Update Submit

January 23, 2017

Conditions

Eye Infections

Keywords

Povidone-IodineOphthalmic SolutionsEndophthalmitisPreoperative procedures

Outcome Measures

Primary Outcomes (1)

  • 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).

    At 30-minute study period, a conjunctival sac swab will be obtained

Secondary Outcomes (1)

  • Difference in corneal thickness change between groups.

    At 35-minute study period.

Study Arms (2)

Povidone-iodine

EXPERIMENTAL

1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.

Other: Povidone-iodine

Povidone-iodine and Saline Solution

ACTIVE COMPARATOR

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%.

Other: Povidone-iodineOther: Saline Solution

Interventions

Povidone-iodineOTHER

Povidone iodine 5% drop will be instilled into conjunctival sac.

Povidone-iodinePovidone-iodine and Saline Solution
Saline SolutionOTHER

1 drop of saline solution 0.9% will be instilled into conjunctival sac.

Povidone-iodine and Saline Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital of Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Eye InfectionsEndophthalmitis

Interventions

Povidone-IodineSaline Solution

Condition Hierarchy (Ancestors)

InfectionsEye Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Rodrigo Jorge, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Leticia F Barroso, MD

    Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 4, 2012

Study Start

May 1, 2011

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

BR(1)