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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05990712
• Other study ID #: UptownEye4
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Uptown Eye Specialists
• Contact: Sohel Somani, MD
• Phone: 416-292-0330
• Email: sohel.somani[@]uptowneye.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Uptown Eye	Brampton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Uptown Eye Specialists	Forsee Canada, WIlliam Osler Health Systems

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Tear osmolarity	Measure of salt concentration in tear reported as mOsm/L	Baseline, 2-5 days prior to surgery, surgery day
Secondary	Non-invasive break-up time (NIBUT)	Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.	Baseline, 2-5 days prior to surgery, post-operative month 1
Secondary	Lipid layer	Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.	Baseline, 2-5 days prior to surgery, post-operative month 1
Secondary	Bulbar redness	Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.	Baseline, 2-5 days prior to surgery, post-operative month 1
Secondary	Tear meniscus height	Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.	Baseline, 2-5 days prior to surgery, post-operative month 1
Secondary	Canadian Dry Eye Assessment (CDEA) Questionnaire	12 item questionnaire for reporting of dry eye symptoms on a scale of 0-4. Total scores for the CDEA questionnaire range from 0 to 48 and are interpreted as no dry eye symptoms or normal (<5), mild dry eye symptoms (5-20), moderate dry eye symptoms (21-30), or severe dry eye symptoms (31-48).	Baseline, 2-5 days prior to surgery, post-operative month 1