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

Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Procedure: Change of normal concentration of povidone-iodine 5% to 1%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 04030
    • Asociación para Evitar la Ceguera en México I.A.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone-iodine 1%; Povidone-iodine 1% was used as antiseptic during anti-VEGF intravitreal injection	Procedure: 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.
Active Comparator: Povidone-iodine 5%; Povidone-iodine 5% was used as antiseptic during anti-VEGF intravitreal injection	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford scale	Oxford scale was measured with fluorescein stain before and after intravitreal injection	Change from baseline measured to 15 minutes post-injection
Pain analog scale	Pain using visual analog scale was measured 15 minutes and 48 hours after intravitreal injection	Change from baseline measured to 15 minutes post-injection

Collaborators and Investigators

• Sponsor: José Gerardo García Aguirre
• Investigators: Principal Investigator: José Gerardo García-Aguirre, Asociación para Evitar la Ceguera en México I.A.P.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Povidone-iodine
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Anti-Infective Agents; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Povidone; Povidone-Iodine
• Other Study ID Numbers: RE-21-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No