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

NCT06710951 | Completed

• 1 other identifier: RE-21-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

Povidone-iodine; Pain

Outcome Measures

Primary Outcomes (2)

• Tear breaking rupture

  NIKBUT was measured with Keratopgraph before and after intravitreal injection

  Change from baseline measured to 15 minutes post-injection

• Bulbar redness

  Bulbar redness was measured with Keratopgraph before and after intravitreal injection

  Change from baseline measured to 15 minutes post-injection

Secondary Outcomes (2)

• Oxford scale

  Change from baseline measured to 15 minutes post-injection

• Pain analog scale

  Change from baseline measured to 15 minutes post-injection

Study Arms (2)

Povidone-iodine 1%

EXPERIMENTAL

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

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

Povidone-iodine 5%

ACTIVE COMPARATOR

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

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

Interventions

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• José Gerardo García Aguirre: lead

Study Sites (1)

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

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Pain

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Gerardo García-Aguirre

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Retina Adjunct

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: November 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 29, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)