Optimizing Preoperative Disinfection of Eyes

Norwegian University of Science and Technology

Status and phase: Terminated; Phase 4

Conditions: Eye Infections

Treatments: Drug: Povidone-Iodine 5%; Drug: Povidone-Iodine 0.3%

Study type: Interventional

Funder types: Other

Identifiers

NCT04745663

SW2019-3

2019-001179-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

Povidone-Iodine 0.3 %

Experimental group

Description:

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.

Treatment:

Drug: Povidone-Iodine 0.3%

Povidone-Iodine 5 %

Active Comparator group

Description:

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.

Treatment:

Drug: Povidone-Iodine 5%