Optimizing Preoperative Disinfection of Eyes

NCT04745663 | Terminated Phase 4

• 2 other identifiers: SW2019-32019-001179-35
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Infections

Keywords

Disinfection; Pre-operative; Povidone Iodine; Eye surgery

Outcome Measures

Primary Outcomes (1)

• Conjunctival bacterial culture

  Change in colony-forming units (CFU) per milliliter (ml)

  1 hour. Bacterial sample is taken before and immediately after disinfection

Secondary Outcomes (2)

• Patient pain score

  During disinfection and after 1 hour when the anesthetic no longer is effective

• Ocular staining score (OSS)

  1 hour after disinfection

Study Arms (2)

Povidone-Iodine 0.3 %

EXPERIMENTAL

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%

Povidone-Iodine 5 %

ACTIVE COMPARATOR

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%

Interventions

Povidone-Iodine 0.3% DRUG

Low concentration iodine

Povidone-Iodine 0.3 %

Povidone-Iodine 5% DRUG

Standard concentration iodine

Povidone-Iodine 5 %

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients remitted to intravitreal injections at St. Olavs hospital.
• Patients competent to give written consent

You may not qualify if:

• Infectious disease
• Known epitheliopathy
• Contact lens wear
• Use of prescription ophthalmic medications
• Diabetes

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Eye Infections

Condition Hierarchy (Ancestors)

Infections; Eye Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 9, 2021
• Study Start: February 8, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

NO (1)