Back to resultsOptimizing Preoperative Disinfection of Eyes
Primary Purpose
Eye Infections
Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Povidone-Iodine 0.3%
Povidone-Iodine 5%
Sponsored by
About this trial
This is an interventional prevention trial for Eye Infections focused on measuring Disinfection, Pre-operative, Povidone Iodine, Eye surgery
Eligibility Criteria
Inclusion Criteria:
- Patients remitted to intravitreal injections at St. Olavs hospital.
- Patients competent to give written consent
Exclusion Criteria:
- Infectious disease
- Known epitheliopathy
- Contact lens wear
- Use of prescription ophthalmic medications
- Diabetes
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Povidone-Iodine 0.3 %
Povidone-Iodine 5 %
Arm Description
A tampon is soaked in diluted PI 0.3% and placed on the inside of the lower eyelid of one eye, where it will release iodine molecules for 20 minutes before being removed.
Eye drops of 5% PI is the standard disinfection before eye surgery. The drops will be dripped in one eye and allowed to work for 2 minutes.
Outcomes
Primary Outcome Measures
Conjunctival bacterial culture
Change in colony-forming units (CFU) per milliliter (ml)
Secondary Outcome Measures
Patient pain score
Verbal numeric rating scale, from 0 to 10.
Ocular staining score (OSS)
Modified OSS using fluorescein dye
Full Information
NCT ID
NCT04745663
First Posted
February 5, 2021
Last Updated
September 6, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04745663
Brief Title
Optimizing Preoperative Disinfection of Eyes
Official Title
Optimizing Preoperative Disinfection of Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Not the expected 2/3 but only 1/3 of conjunctiva samples got bacterial growth. Lack of resources to keep the study going with more participants and over a considerably longer time than anticipated.
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections
Keywords
Disinfection, Pre-operative, Povidone Iodine, Eye surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Povidone-Iodine 0.3 %
Arm Type
Experimental
Arm Description
A tampon is soaked in diluted PI 0.3% and placed on the inside of the lower eyelid of one eye, where it will release iodine molecules for 20 minutes before being removed.
Arm Title
Povidone-Iodine 5 %
Arm Type
Active Comparator
Arm Description
Eye drops of 5% PI is the standard disinfection before eye surgery. The drops will be dripped in one eye and allowed to work for 2 minutes.
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine 0.3%
Intervention Description
Low concentration iodine
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine 5%
Intervention Description
Standard concentration iodine
Primary Outcome Measure Information:
Title
Conjunctival bacterial culture
Description
Change in colony-forming units (CFU) per milliliter (ml)
Time Frame
1 hour. Bacterial sample is taken before and immediately after disinfection
Secondary Outcome Measure Information:
Title
Patient pain score
Description
Verbal numeric rating scale, from 0 to 10.
Time Frame
During disinfection and after 1 hour when the anesthetic no longer is effective
Title
Ocular staining score (OSS)
Description
Modified OSS using fluorescein dye
Time Frame
1 hour after disinfection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients remitted to intravitreal injections at St. Olavs hospital.
Patients competent to give written consent
Exclusion Criteria:
Infectious disease
Known epitheliopathy
Contact lens wear
Use of prescription ophthalmic medications
Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marit Fagerli, MD
Organizational Affiliation
Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
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Optimizing Preoperative Disinfection of Eyes
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