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Procedure

Systane iLux for Dry Eye Syndrome

N/A
Recruiting
Led By Keith Wroblewski, MD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Upcoming scheduled senile cataract surgery
Age greater than 18 at the time of informed consent
Must not have
Previous application/administration of Systane iLux or LipiFlow treatment
Eyelid abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial will look at how using the Systane iLux system before cataract surgery can help with dry eyes caused by the cataract.

Who is the study for?
This trial is for individuals with dry eye disease due to Meibomian Gland Dysfunction who are scheduled for cataract surgery. The study aims to include those who meet specific health criteria, but the exact inclusion and exclusion details aren't provided here.
What is being tested?
The trial is testing the effectiveness of a treatment called Systane iLux, which is administered before cataract surgery to see if it can improve symptoms of dry eye caused by Meibomian Gland Dysfunction.
What are the potential side effects?
Potential side effects are not detailed in this summary. However, as with any medical intervention, there may be risks involved which will be explained by the research team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for cataract surgery due to aging.
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously used Systane iLux or LipiFlow for my eyes.
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I have an abnormality with my eyelids.
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I have scarring on my eyelid edges.
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I have issues with my eyelid that affect its movement or function.
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I do not have an active eye infection or inflammation, nor a history of it in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changed in Lipid Layer Thickness (LLT) measurement from baseline visit
Secondary study objectives
Change from baseline in Meibomian Gland Score (MGS)
Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit
Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Systane iLux TreatmentExperimental Treatment1 Intervention
Systane iLux administration at baseline visit two weeks prior to cataract surgery.
Group II: Control: No Systane iLux TreatmentActive Control1 Intervention
No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.

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Who is running the clinical trial?

George Washington UniversityLead Sponsor
250 Previous Clinical Trials
458,760 Total Patients Enrolled
Keith Wroblewski, MDPrincipal InvestigatorGeorge Washington MFA
~33 spots leftby Sep 2025
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