Hypochlorous Acid Disinfection Prior to Cataract Surgery

NCT ID: NCT04568213

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2022-12-09

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Endophthalmitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hypochlorous Gel Application

Group Type EXPERIMENTAL

Hypochlorous Acid Gel 0.02%

Intervention Type 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.

Interventions

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Hypochlorous Acid Gel 0.02%

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Patients undergoing cataract surgery.

Exclusion Criteria

* Age \<18 years old
* Vulnerable subjects
* Non-English Speakers
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey J Ing, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Department of Ophthalmology

Locations

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Loma Linda University Health

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5200306

Identifier Type: -

Identifier Source: org_study_id

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