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Procedure
Intense Pulsed Light for Dry Eye Syndrome
N/A
Waitlist Available
Research Sponsored by Quantel Medical
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 60 days
Summary
This trial aims to test the effectiveness and safety of a device called C.STIM, which uses intense pulsed light to treat dry eye disease. The main focus is to see how Tear Break-Up time
Who is the study for?
This trial is for individuals with dry eye disease who can attend an initial evaluation, four treatment sessions, and a final assessment. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.
What is being tested?
The study tests the effectiveness and safety of the C.STIM device, which uses intense pulsed light to treat dry eye symptoms. Participants will be split into two groups: one receiving the actual treatment and another receiving a placebo.
What are the potential side effects?
While specific side effects are not listed for this trial, intense pulsed light treatments may sometimes cause discomfort, redness or swelling in treated areas. These effects are generally mild and temporary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tear Break-Up Time evolution
Secondary study objectives
Glaucoma
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Meibum Expressibility
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intense Pulsed Light treated armExperimental Treatment1 Intervention
The treatment consists in Intense Pulsed Light C.STIM® with recommended fluence.
Group II: Very low fluence Intense Pulsed Light arm (placebo)Placebo Group1 Intervention
The treatment consists in Intense Pulsed Light C.STIM® with a very low fluence.
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Who is running the clinical trial?
Quantel MedicalLead Sponsor
2 Previous Clinical Trials
169 Total Patients Enrolled
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