The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers
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ClinicalTrials.gov Identifier: NCT05990712 |
Recruitment Status :
Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
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Condition or disease | Intervention/treatment | Phase |
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Dry Eye Dry Eye Syndromes Cataract | Dietary Supplement: Omega-3 Drug: Trehalose Drug: Zocular Eyelid System Treatment Other: Blephadex cleansing eyelid wipes | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be assigned to either the omega-3 group or no omega-3 group. |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | January 1, 2024 |
Estimated Study Completion Date : | January 1, 2024 |
Arm | Intervention/treatment |
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Experimental: Omega-3
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.
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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.
Other Name: Thealoz Duo Drops 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 Name: ZEST Other: Blephadex cleansing eyelid wipes Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection. |
Active Comparator: No Omega-3
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.
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Drug: Trehalose
Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.
Other Name: Thealoz Duo Drops 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 Name: ZEST Other: Blephadex cleansing eyelid wipes Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection. |
- MMP-9 [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]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 [ Time Frame: Baseline, 2-5 days prior to surgery, surgery day ]Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
- Tear osmolarity [ Time Frame: Baseline, 2-5 days prior to surgery, surgery day ]Measure of salt concentration in tear reported as mOsm/L
- Non-invasive break-up time (NIBUT) [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.
- Lipid layer [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.
- Bulbar redness [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.
- Tear meniscus height [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.
- Canadian Dry Eye Assessment (CDEA) Questionnaire [ Time Frame: Baseline, 2-5 days prior to surgery, post-operative month 1 ]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).
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990712
Contact: Sohel Somani, MD | 416-292-0330 | sohel.somani@uptowneye.ca |
Canada, Ontario | |
Uptown Eye | |
Brampton, Ontario, Canada, L6Y 0P6 | |
Contact: Sohel Somani, MD sohel.somani@uptowneye.ca |
Responsible Party: | Uptown Eye Specialists |
ClinicalTrials.gov Identifier: | NCT05990712 |
Other Study ID Numbers: |
UptownEye4 |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | August 14, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Pre-operative Ocular hygiene Omega 3 |
Microbial load Inflammation Tear osmolarity |
Cataract Dry Eye Syndromes Keratoconjunctivitis Sicca Lens Diseases Eye Diseases Lacrimal Apparatus Diseases |
Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |