Clinical trial NCT05990712: The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Dry Eye Syndromes
Cataract
Keywords: Pre-operative
Ocular hygiene
Omega 3
Microbial load
Inflammation
Tear osmolarity
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
Collaborators: name: WIlliam Osler Health Systems
name: Forsee Canada
First posted: 2023-08-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to either the omega-3 group or no omega-3 group.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: MMP-9
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
measure: Microbial load
timeFrame: Baseline, 2-5 days prior to surgery, surgery day
measure: Tear osmolarity
timeFrame: Baseline, 2-5 days prior to surgery, surgery day
Secondary outcomes:
measure: Non-invasive break-up time (NIBUT)
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
measure: Lipid layer
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
measure: Bulbar redness
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
measure: Tear meniscus height
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
measure: Canadian Dry Eye Assessment (CDEA) Questionnaire
timeFrame: Baseline, 2-5 days prior to surgery, post-operative month 1
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Uptown Eye
state: Ontario
Study officials:
References: