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OpenTrials
Completed

NCT Number: NCT06710951

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mexico City, 04030, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Tear breaking rupture

    Time frame: Change from baseline measured to 15 minutes post-injection

    NIKBUT was measured with Keratopgraph before and after intravitreal injection

  2. Bulbar redness

    Time frame: Change from baseline measured to 15 minutes post-injection

    Bulbar redness was measured with Keratopgraph before and after intravitreal injection

Secondary outcomes

  1. Oxford scale

    Time frame: Change from baseline measured to 15 minutes post-injection

    Oxford scale was measured with fluorescein stain before and after intravitreal injection

  2. Pain analog scale

    Time frame: Change from baseline measured to 15 minutes post-injection

    Pain using visual analog scale was measured 15 minutes and 48 hours after intravitreal injection

Sponsors and collaborators

Lead sponsor

José Gerardo García Aguirre

Other

Registry information

Official study title

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

Acronym: anti-VEGF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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