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Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF

NCT ID: NCT06710951

Last Updated: 2024-11-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-06-30

Brief Summary

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Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection

Detailed Description

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Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.

Conditions

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Dry Eye

Keywords

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Povidone-iodine Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Patients did not know which percentage of povidone-iodine was utilized during their injection.

Tear breaking time and bulbar redness were automized results by Keraatopgrah. Oxford scale pre and post injection was staged by an investigator that did not know the group in which the patient was.

Study Groups

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Povidone-iodine 1%

Povidone-iodine 1% was used as antiseptic during anti-VEGF intravitreal injection

Group Type EXPERIMENTAL

Change of normal concentration of povidone-iodine 5% to 1%

Intervention Type PROCEDURE

Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.

Povidone-iodine 5%

Povidone-iodine 5% was used as antiseptic during anti-VEGF intravitreal injection

Group Type ACTIVE_COMPARATOR

Change of normal concentration of povidone-iodine 5% to 1%

Intervention Type PROCEDURE

Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.

Interventions

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Change of normal concentration of povidone-iodine 5% to 1%

Normal concentration of povidone-iodine during anti-VEGF intravitreal injection was 5%. That concentration was utilized in the control group, and 1% in the experimental group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Having anti-VGEF intravitreal injection scheduled
* Informed consent signed

Exclusion Criteria

* Under 45 years
* Opacity that prevents ophthalmological evaluation and fixation
* Patients with severe dry eye
* Patients with signs of infection on the ocular surface
* Allergy to iodine
* Pregnancy
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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José Gerardo García Aguirre

OTHER

Sponsor Role lead

Responsible Party

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José Gerardo García Aguirre

Retina Adjunct

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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José Gerardo García-Aguirre

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México I.A.P.

Locations

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Asociación para Evitar la Ceguera en México I.A.P.

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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RE-21-02

Identifier Type: -

Identifier Source: org_study_id