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Procedure

Intense Pulsed Light treated arm for Dry Eye Syndrome

N/A
Recruiting
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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tear Break-Up Time evolution
Secondary outcome measures
Glaucoma
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Meibum Expressibility
+3 more

Trial 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.

Find a Location

Who is running the clinical trial?

Quantel MedicalLead Sponsor
2 Previous Clinical Trials
169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for patient enrollment in this particular clinical investigation?

"A minimum of 100 eligible participants are required to conduct this clinical investigation. The organization behind the study, Quantel Medical, will oversee operations at various locations such as Triangle Eye Consultants in Raleigh, North carolina and Visionary Consultants Inc. in Lexington, Kentucky."

Answered by AI

Are they currently accepting participants for this research study?

"Information available on clinicaltrials.gov confirms that this investigation is actively seeking volunteers. The trial was initially published on March 28, 2023 and last revised on March 29, 2024."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"Recruitment for this study is ongoing at 4 sites, including Raleigh, Lexington, and Kenosha, as well as additional locations in 4 other cities. Opting for the nearest clinic is advised to reduce travel demands if you decide to partake."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"
2023. "Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06349356.
All > High Point > Greensboro
~28 spots leftby Sep 2024
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