Hypochlorous Acid Disinfection Prior to Cataract Surgery

Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.

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Key information

Conditions

Cataract Endophthalmitis Eye Diseases Eye Infections Infections Lens Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University Health

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients undergoing cataract surgery.

Exclusion criteria

Age <18 years old
Vulnerable subjects
Non-English Speakers

Treatment and study plan

Hypochlorous Acid Gel 0.02%

Drug

0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball.

Primary outcomes

Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye

Time frame: On day of surgery prior to surgical prep

Swab will be used to obtain samples from the eyelashes bilaterally and cultured
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow

Time frame: On day of surgery prior to surgical prep

Swab will be used to obtain samples from the conjunctiva bilaterally and cultured

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Sep 29, 2020
Registry last updated: Feb 21, 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.

Published trials that share one or more normalized conditions with this study.

Completed