NCT05990712

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

A Prospective Study on the Effect of Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers Between Two Ocular Hygiene Regimen Groups

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Uptown Eye Specialists · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study