Optimizing Preoperative Disinfection of Eyes

Eye Infections Clinical Trial

Official title:

Optimizing Preoperative Disinfection of Eyes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04745663
• Other study ID #: SW2019-3
• Secondary ID: 2019-001179-35
• Status: Terminated
• Phase: Phase 4
• Start date: February 8, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Infections

Intervention

Drug:
• Povidone-Iodine 0.3%
Low concentration iodine
• Povidone-Iodine 5%
Standard concentration iodine

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival bacterial culture	Change in colony-forming units (CFU) per milliliter (ml)	1 hour. Bacterial sample is taken before and immediately after disinfection
Secondary	Patient pain score	Verbal numeric rating scale, from 0 to 10.	During disinfection and after 1 hour when the anesthetic no longer is effective
Secondary	Ocular staining score (OSS)	Modified OSS using fluorescein dye	1 hour after disinfection