The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers

Summary

This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.

Conditions

• Dry Eye
• Dry Eye Syndromes
• Cataract

Interventions

DIETARY_SUPPLEMENT

Omega-3

Omega-3 is a fatty acid and there is evidence that the consumption of re-esterified oral omega-3 supplements over the course of 6 to 8 weeks aid in reducing inflammation, dry eye, and optimizing tear osmolarity. The oral omega-3 supplement taken daily.

DRUG

Trehalose

Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.

DRUG

Zocular Eyelid System Treatment

A lid cleaning and debridement system that consists of okra-based gel to relieve dry eye or inflammation. The gel is applied to the eyelid margin and lashes with a cotton swab.

OTHER

Blephadex cleansing eyelid wipes

Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection.

Sponsors & Collaborators

• WIlliam Osler Health Systems

  collaborator UNKNOWN

• Forsee Canada

  collaborator UNKNOWN

• Uptown Eye Specialists

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2024-01-01

Completion

2024-01-01

FDA Drug

Yes

Countries

• Canada

Study Locations