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

NCT05990712 | Unknown Phase 4 FDA Drug

• 1 other identifier: UptownEye4
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndromes; Cataract

Keywords

Pre-operative; Ocular hygiene; Omega 3; Microbial load; Inflammation; Tear osmolarity

Outcome Measures

Primary Outcomes (3)

• MMP-9

  Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 \> 40ng/mL) or negative (level of MMP-9 \< 40ng/mL).

  Baseline, 2-5 days prior to surgery, post-operative month 1

• Microbial load

  Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours

  Baseline, 2-5 days prior to surgery, surgery day

• Tear osmolarity

  Measure of salt concentration in tear reported as mOsm/L

  Baseline, 2-5 days prior to surgery, surgery day

Secondary Outcomes (5)

• Non-invasive break-up time (NIBUT)

  Baseline, 2-5 days prior to surgery, post-operative month 1

• Lipid layer

  Baseline, 2-5 days prior to surgery, post-operative month 1

• Bulbar redness

  Baseline, 2-5 days prior to surgery, post-operative month 1

• Tear meniscus height

  Baseline, 2-5 days prior to surgery, post-operative month 1

• Canadian Dry Eye Assessment (CDEA) Questionnaire

  Baseline, 2-5 days prior to surgery, post-operative month 1

Study Arms (2)

Omega-3

EXPERIMENTAL

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.

Dietary Supplement: Omega-3; Drug: Trehalose; Drug: Zocular Eyelid System Treatment; Other: Blephadex cleansing eyelid wipes

No Omega-3

ACTIVE COMPARATOR

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.

Drug: Trehalose; Drug: Zocular Eyelid System Treatment; Other: Blephadex cleansing eyelid wipes

Interventions

Omega-3 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.

Omega-3

Trehalose DRUG

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

Also known as: Thealoz Duo Drops

No Omega-3; Omega-3

Zocular Eyelid System Treatment 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.

Also known as: ZEST

No Omega-3; Omega-3

Blephadex cleansing eyelid wipes OTHER

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

No Omega-3; Omega-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uptown Eye Specialists: lead
• WIlliam Osler Health Systems: collaborator
• Forsee Canada: collaborator

Study Sites (1)

Uptown Eye

Brampton, Ontario, L6Y 0P6, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract; Inflammation

Interventions

Docosahexaenoic Acids; Trehalose

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Central Study Contacts

Sohel Somani, MD

CONTACT

416-292-0330; sohel.somani@uptowneye.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to either the omega-3 group or no omega-3 group.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)