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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
254 Previous Clinical Trials
466,545 Total Patients Enrolled
Keith Wroblewski, MDPrincipal InvestigatorGeorge Washington MFA