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Ocular Hygiene Regimen for Cataracts and Dry Eye
Phase 4
Waitlist Available
Research Sponsored by Uptown Eye Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2-5 days prior to surgery, post-operative month 1
Awards & highlights
Study Summary
This trial will assess the impact of using an omega-3 supplement and at-home lid wipes/eye drops before cataract surgery on inflammation, microbial load, tear osmolarity, and dry eye metrics.
Who is the study for?
This trial is for adults over 18 with any severity of dry eye syndrome who are undergoing cataract surgery. It's not for those unable to consent, with other eye conditions, systemic autoimmune or immune disorders, blood disorders, prior eye surgeries or treatments like ocular plugs.Check my eligibility
What is being tested?
The study compares two pre-cataract surgery hygiene regimens: one includes omega-3 supplements and the other does not; both use lid wipes and cleansing drops. The effects on microbial load, inflammation markers, tear osmolarity, and dry eye symptoms will be measured.See study design
What are the potential side effects?
Potential side effects may include irritation from eyelid wipes or cleansing drops and allergic reactions to omega-3 supplements. Discomfort during swabbing for microbial load assessment might occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2-5 days prior to surgery, post-operative month 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2-5 days prior to surgery, post-operative month 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MMP-9
Microbial load
Tear osmolarity
Secondary outcome measures
Bulbar redness
Canadian Dry Eye Assessment (CDEA) Questionnaire
Lipid layer
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Omega-3Experimental Treatment4 Interventions
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.
Group II: No Omega-3Active Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3
2012
Completed Phase 4
~1760
Trehalose
2016
Completed Phase 3
~100
Zocular Eyelid System Treatment
2019
N/A
~30
Find a Location
Who is running the clinical trial?
Uptown Eye SpecialistsLead Sponsor
10 Previous Clinical Trials
1,265 Total Patients Enrolled
WIlliam Osler Health SystemsUNKNOWN
Forsee CanadaUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with any level of dry eye will be allowed to participate.You experienced any complications during your cataract surgery.You have other eye problems like glaucoma or iritis, or you have certain medical conditions that affect your immune system or blood.
Research Study Groups:
This trial has the following groups:- Group 1: Omega-3
- Group 2: No Omega-3
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What regulatory endorsements has Omega-3 garnered?
"While past studies have suggested Omega-3's safety, this Phase 4 medical trial confirms the efficacy of its use. Consequently, our team rated it a 3 on our scale from 1 to 3."
Answered by AI
What are the main goals of this experiment?
"The main objective of this investigation is to measure the microbial load over three given points in time: Baseline, pre-operative (2-5 days before surgery), and post-surgical month 1. Secondary outcomes include Lipid Layer thickness, Bulbar Redness scores, and Tear Meniscus Height values - all measured according to their respective scales with higher/lower ratings indicating a better outcome."
Answered by AI
Is the enrollment period still open for this experiment?
"According to clinicaltrials.gov this research initiative is not currently seeking participants, having originally been posted on September 1st 2023 and last amended on August 6th. Nevertheless, there are 209 other studies recruiting patients in the present moment."
Answered by AI
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