Optimizing Preoperative Disinfection of Eyes

Phase 4TerminatedNCT04745663

Norwegian University of Science and Technology150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Eye Infections

Interventions

Povidone-Iodine 0.3%DRUG

Low concentration iodine

Povidone-Iodine 5%DRUG

Standard concentration iodine

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

Conjunctival bacterial culture

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

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

Secondary Outcomes

Patient pain score

Verbal numeric rating scale, from 0 to 10.

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

Ocular staining score (OSS)

Modified OSS using fluorescein dye

Time frame: 1 hour after disinfection

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.