Optimizing Preoperative Disinfection of Eyes
Phase 4
Terminated
- Conditions
- Eye Infections
- Interventions
- Registration Number
- NCT04745663
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povidone-Iodine 5 % 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. Povidone-Iodine 0.3 % 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.
- Primary Outcome Measures
Name Time Method Conjunctival bacterial culture 1 hour. Bacterial sample is taken before and immediately after disinfection Change in colony-forming units (CFU) per milliliter (ml)
- Secondary Outcome Measures
Name Time Method Patient pain score During disinfection and after 1 hour when the anesthetic no longer is effective Verbal numeric rating scale, from 0 to 10.
Ocular staining score (OSS) 1 hour after disinfection Modified OSS using fluorescein dye
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway