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

Primary Purpose

Dry Eye, Dry Eye Syndromes, Cataract

Status
Not yet recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Omega-3
Trehalose
Zocular Eyelid System Treatment
Blephadex cleansing eyelid wipes
Sponsored by
Uptown Eye Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye focused on measuring Pre-operative, Ocular hygiene, Omega 3, Microbial load, Inflammation, Tear osmolarity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uptown Eye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omega-3

No Omega-3

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Microbial load
Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
Tear osmolarity
Measure of salt concentration in tear reported as mOsm/L

Secondary Outcome Measures

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.
Lipid layer
Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.
Bulbar redness
Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.
Tear meniscus height
Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.
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).

Full Information

First Posted
July 31, 2023
Last Updated
August 6, 2023
Sponsor
Uptown Eye Specialists
Collaborators
WIlliam Osler Health Systems, Forsee Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05990712
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptown Eye Specialists
Collaborators
WIlliam Osler Health Systems, Forsee Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes, Cataract
Keywords
Pre-operative, Ocular hygiene, Omega 3, Microbial load, Inflammation, Tear osmolarity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to either the omega-3 group or no omega-3 group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
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.
Arm Title
No Omega-3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
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
Drug
Intervention Name(s)
Trehalose
Other Intervention Name(s)
Thealoz Duo Drops
Intervention Description
Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.
Intervention Type
Drug
Intervention Name(s)
Zocular Eyelid System Treatment
Other Intervention Name(s)
ZEST
Intervention Description
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
Other
Intervention Name(s)
Blephadex cleansing eyelid wipes
Intervention Description
Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection.
Primary Outcome Measure Information:
Title
MMP-9
Description
Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 > 40ng/mL) or negative (level of MMP-9 < 40ng/mL).
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1
Title
Microbial load
Description
Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
Time Frame
Baseline, 2-5 days prior to surgery, surgery day
Title
Tear osmolarity
Description
Measure of salt concentration in tear reported as mOsm/L
Time Frame
Baseline, 2-5 days prior to surgery, surgery day
Secondary Outcome Measure Information:
Title
Non-invasive break-up time (NIBUT)
Description
Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1
Title
Lipid layer
Description
Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1
Title
Bulbar redness
Description
Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1
Title
Tear meniscus height
Description
Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1
Title
Canadian Dry Eye Assessment (CDEA) Questionnaire
Description
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).
Time Frame
Baseline, 2-5 days prior to surgery, post-operative month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohel Somani, MD
Phone
416-292-0330
Email
sohel.somani@uptowneye.ca
Facility Information:
Facility Name
Uptown Eye
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y 0P6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohel Somani, MD
Email
sohel.somani@uptowneye.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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