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OpenTrials
Completed

NCT Number: NCT05974124

Effectiveness of Ophthalmic Antiseptic Preparations

The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.

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Key information

Conditions

Antiseptics Conjunctiva Microbiota

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

About this study

70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing cataract surgery
  • 18 years of age or older

Exclusion criteria

  • Reported allergy or hypersensitivity to iodine or chlorhexidine
  • Active ocular infection
  • Contraindication to surgery
  • Pregnant women
  • Patients residing in nursing homes or prison
  • Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention

Treatment and study plan

Povidone-Iodine 0.66%

Device

Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.

Chlorhexidine 0.02%

Device

Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.

Primary outcomes

  1. Conjunctival composition

    Time frame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.

    Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota

Secondary outcomes

  1. Patient pain score

    Time frame: Day 3: after 3 days of treatment

    Numerical rating scale, from 0 to 10

  2. Compliance of the patients

    Time frame: Day 3: after 3 days of treatment

    Questionnaire about patients' compliance

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Collaborators

  • European School of Advanced Studies in Ophthalmology

Registry information

Official study title

Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Aug 4, 2023

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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