Optimizing Preoperative Disinfection of Eyes

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.

Study Overview

• Status: Terminated
• Conditions: Eye Infections
• Intervention / Treatment: Drug: Povidone-Iodine 0.3%; Drug: Povidone-Iodine 5%

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone-Iodine 0.3 %; 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.	Drug: Povidone-Iodine 0.3%; Low concentration iodine
Active Comparator: Povidone-Iodine 5 %; 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.	Drug: Povidone-Iodine 5%; Standard concentration iodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conjunctival bacterial culture	Change in colony-forming units (CFU) per milliliter (ml)	1 hour. Bacterial sample is taken before and immediately after disinfection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain score	Verbal numeric rating scale, from 0 to 10.	During disinfection and after 1 hour when the anesthetic no longer is effective
Ocular staining score (OSS)	Modified OSS using fluorescein dye	1 hour after disinfection

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Jorunn Helbostad, MD PhD, Norwegian University of Science and Technology; Study Director: Marit Fagerli, MD, Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Povidone Iodine; Disinfection; Pre-operative; Eye surgery
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Plasma Substitutes; Blood Substitutes; Iodine; Cadexomer iodine; Povidone-Iodine; Povidone
• Other Study ID Numbers: SW2019-3; 2019-001179-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No