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

Not Applicable

Completed

• Conditions: Dry Eye

• Registration Number: NCT06710951
• Lead Sponsor: José Gerardo García Aguirre

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

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 Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tear breaking rupture	Change from baseline measured to 15 minutes post-injection	NIKBUT was measured with Keratopgraph before and after intravitreal injection
Bulbar redness	Change from baseline measured to 15 minutes post-injection	Bulbar redness was measured with Keratopgraph before and after intravitreal injection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asociación para Evitar la Ceguera en México I.A.P.; 🇲🇽 Mexico City, Mexico