Hypochlorous Acid Disinfection Prior to Cataract Surgery

Phase 3

Completed

• Conditions: Cataract; Endophthalmitis
• Interventions: Drug: Hypochlorous Acid Gel 0.02%

• Registration Number: NCT04568213
• Lead Sponsor: Loma Linda University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-29
• Study Start: 2020-10-29
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients undergoing cataract surgery.

Exclusion Criteria

• Age <18 years old
• Vulnerable subjects
• Non-English Speakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypochlorous Gel Application	Hypochlorous Acid Gel 0.02%	-

Primary Outcome Measures

Name	Time	Method
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow	On day of surgery prior to surgical prep	Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye	On day of surgery prior to surgical prep	Swab will be used to obtain samples from the eyelashes bilaterally and cultured

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States