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Optimizing Preoperative Disinfection of Eyes

Optimizing Preoperative Disinfection of Eyes

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04745663
Enrollment
150
Registered
2021-02-09
Start date
2021-02-08
Completion date
2021-04-30
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Infections

Keywords

Disinfection, Pre-operative, Povidone Iodine, Eye surgery

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.

Interventions

DRUGPovidone-Iodine 0.3%

Low concentration iodine

DRUGPovidone-Iodine 5%

Standard concentration iodine

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Conjunctival bacterial culture1 hour. Bacterial sample is taken before and immediately after disinfectionChange in colony-forming units (CFU) per milliliter (ml)

Secondary

MeasureTime frameDescription
Patient pain scoreDuring disinfection and after 1 hour when the anesthetic no longer is effectiveVerbal numeric rating scale, from 0 to 10.
Ocular staining score (OSS)1 hour after disinfectionModified OSS using fluorescein dye

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026