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CompletedNCT06710951anti-VEGFUpdated Nov 29, 2024

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

An interventional study of Change of normal concentration of povidone-iodine 5% to 1% in Dry Eye, sponsored by José Gerardo García Aguirre. Completed at 1 site in Mexico. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by José Gerardo García Aguirre · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Nov 2021, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dry Eye

Keywords

  • Povidone-iodine
  • Pain
03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 88 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

This is the only study on the registry with José Gerardo García Aguirre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (actual)

Study arms

  • 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%

  • 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%

Interventions

  • ProcedureChange 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.

06

What researchers measure

Primary outcomes

  1. Tear breaking rupture

    NIKBUT was measured with Keratopgraph before and after intravitreal injection

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

  2. Bulbar redness

    Bulbar redness was measured with Keratopgraph before and after intravitreal injection

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

Secondary outcomes

  1. Oxford scale

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

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

  2. Pain analog scale

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

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

07

Study locations

1 site
  • Asociación para Evitar la Ceguera en México I.A.P.
    Mexico City, Mexico City 04030, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06710951
Lead sponsor
José Gerardo García Aguirre
Responsible party
José Gerardo García Aguirre (Retina Adjunct, Asociación para Evitar la Ceguera en México) — Sponsor-investigator
First posted
Nov 29, 2024
Start date
Nov 15, 2021
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Nov 29, 2024

Study contacts

José Gerardo García-Aguirre
principal investigator · Asociación para Evitar la Ceguera en México I.A.P.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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