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

NCT ID: NCT05990712

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-01-01

Brief 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.

Detailed Description

Prospective interventional study assessing the impact of two ocular hygiene regimens, with and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics and disease for patients soon to undergo cataract surgery. Study recruitment will occur at Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study. Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3 group will take the supplement from baseline until one month post-operative.

Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9 (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC) appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and post-operative month. An ocular assessment will also be completed at baseline, one week post-operation, and post-operative month. All metrics will be compared to the fellow eye.

Conditions

Dry Eye; Dry Eye Syndromes; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Omega-3

Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Group Type: EXPERIMENTAL

Omega-3

Intervention Type: DIETARY_SUPPLEMENT

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.

Trehalose

Intervention Type: DRUG

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

Zocular Eyelid System Treatment

Intervention Type: DRUG

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.

Blephadex cleansing eyelid wipes

Intervention Type: OTHER

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

No Omega-3

Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Group Type: ACTIVE_COMPARATOR

Trehalose

Intervention Type: DRUG

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

Zocular Eyelid System Treatment

Intervention Type: DRUG

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.

Blephadex cleansing eyelid wipes

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Trehalose

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

Intervention Type: 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.

Intervention Type: DRUG

Blephadex cleansing eyelid wipes

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

Intervention Type: OTHER

Other Intervention Names

Thealoz Duo Drops; ZEST

Eligibility Criteria

Inclusion Criteria

• Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen prior to cataract surgery.
• Patients of all severity of dry eye will be included.

Exclusion Criteria

• Patients with any other ocular comorbidities (glaucoma, iritis, traumatic eye injury, known systemic autoimmune diseases, immune disorders, anti-inflammatory medications, blood disorders (eg. altered white counts), prior surgery, prior traumatic eye injury, previous dry eye interventions such as ocular plugs, radiofrequency, and IPL).
• Patients who have any complications arise during the cataract surgery.
• Patients with altered mental state and cannot provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WIlliam Osler Health Systems

UNKNOWN

Sponsor Role: collaborator

Forsee Canada

UNKNOWN

Sponsor Role: collaborator

Uptown Eye Specialists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uptown Eye

Brampton, Ontario, Canada

Countries

Canada

Central Contacts

Sohel Somani, MD

Role: CONTACT

sohel.somani@uptowneye.ca

416-292-0330

Facility Contacts

Sohel Somani, MD

Role: primary

sohel.somani@uptowneye.ca

Other Identifiers

UptownEye4

Identifier Type: -

Identifier Source: org_study_id