Optimizing Preoperative Disinfection of Eyes

NCT ID: NCT04745663

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Eye Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Povidone-Iodine 0.3%

Intervention Type DRUG

Low concentration iodine

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.

Group Type ACTIVE_COMPARATOR

Povidone-Iodine 5%

Intervention Type DRUG

Standard concentration iodine

Interventions

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Povidone-Iodine 0.3%

Low concentration iodine

Intervention Type DRUG

Povidone-Iodine 5%

Standard concentration iodine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorunn Helbostad, MD PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Marit Fagerli, MD

Role: STUDY_DIRECTOR

Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2019-001179-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SW2019-3

Identifier Type: -

Identifier Source: org_study_id

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