Intense Pulsed Light for Chalazion

Recruiting at 1 trial location

Overseen By Haya Hamza, Bsc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lumenis Be Ltd.

Must not be taking: Photosensitive medications

Disqualifiers: Chronic chalazion, Malignant tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a treatment called OptiLIGHT, which uses intense pulsed light (IPL), for removing chalazion (a swollen, painful bump on the eyelid). Researchers aim to determine if this light treatment is safe and effective compared to a sham treatment. It targets individuals who have had a chalazion for less than four weeks. Participants should not have received IPL in the last six months or have other eyelid issues. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for chalazion.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used certain medications like Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort within 3 months before screening.

What prior data suggests that this IPL treatment is safe for treating Chalazion?

Research has shown that intense pulsed light (IPL) treatment, such as OptiLIGHT, is generally safe for individuals with chalazion, a common eyelid bump. One study found that IPL treatment significantly reduced the size of chalazia without requiring surgery, and no harmful effects were reported. Another study demonstrated that IPL, when combined with a specific treatment plan, was 96.15% effective, with no observed side effects. This indicates that OptiLIGHT is well-tolerated by patients. Although new treatments always carry some risk, current evidence supports the safety of IPL therapy for chalazion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chalazion, which often involve warm compresses, steroid injections, or surgical removal, OptiLIGHT uses Intense Pulsed Light (IPL) therapy. This non-invasive approach targets the root causes of chalazion by improving the function of the meibomian glands and reducing inflammation. Researchers are excited about OptiLIGHT because it offers a non-surgical alternative that could potentially provide faster relief with fewer side effects, making it a promising option for patients seeking less invasive treatments.

What evidence suggests that OptiLIGHT is effective for treating Chalazion?

Research has shown that Intense Pulsed Light (IPL) treatment, such as OptiLIGHT, can significantly aid in managing chalazion. In this trial, participants in the study arm will receive active IPL treatment. One study found that using IPL with other treatments succeeded 96.15% of the time, with no negative side effects. Another study found that IPL alone improved conditions in about 74.67% of cases. This indicates that IPL can effectively reduce symptoms and prevent chalazion recurrence. Additionally, IPL has improved eye health in related conditions, supporting its potential benefits for individuals with chalazion. ^{3 4 6 7 8}

Who Is on the Research Team?

James Chelnis, MD

Principal Investigator

Manhattan Face and Eye

Laura Periman, MD

Principal Investigator

Periman Eye Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a clinical diagnosis of acute chalazion in the left eye, present for up to 4 weeks. Participants must be able to consent and follow study procedures. Excluded are those with recent IPL treatment, poor vision, active sunburn or severe allergies affecting eyes, recent ocular surgery or trauma, eyelid tumors, certain past surgeries like RK or LASIK/SMILE within specific timeframes.

Inclusion Criteria

Subject is able to read, understand, and sign an Informed Consent Form (ICF)

Subject is willing to comply with all study procedures

I have been diagnosed with a chalazion for no more than 4 weeks.

Exclusion Criteria

I have not had IPL treatment in the last 6 months.

Best corrected visual acuity worse than 20/200 in either eye

Any condition deemed inappropriate for this study by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active IPL treatment or sham IPL treatment

4 weeks

Weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OptiLIGHT

Trial Overview

The trial evaluates the effectiveness and safety of OptiLIGHT therapy on individuals with Chalazion. It aims to determine if this intense pulsed light treatment can effectively treat the condition without causing significant side effects.

How Is the Trial Designed?

Group I: Study arm Experimental Treatment 1 Intervention

subjects in the study arm will receive active IPL treatment

Group II: Control arm Placebo Group 1 Intervention

subjects in the control arm will receive sham IPL treatment

Who Is Running the Clinical Trial?

Lumenis Be Ltd.

Lead Sponsor

Trials

39

Recruited

1,500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8921764/

Efficacy of Intense Pulsed Light in the Treatment ...

The combination of IPL treatment and MGX offers a low risk and effective option in decreasing the recurrence rate of recurrent chalaziosis by improving ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2173579422001074

Intense pulsed light combined with meibomian gland ...

The combined treatment of IPL protocol and GM expression showed 96.15% efficacy and no adverse effects were observed. Conclusions. Combined IPL treatment for ...

3.

nature.com

nature.com/articles/s41598-024-54161-2

Therapeutic effect of intense pulsed light on different types ...

In our study, IPL treatment achieved an improvement rate reaching as high as 74.67%, significantly surpassing Wu AY's conservative approach ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07039461

Study Details | NCT07039461 | Evaluation of Effectiveness ...

Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion. ClinicalTrials.gov ID NCT07039461. Sponsor Lumenis ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10390460/

Novel treatment of chalazion using light-guided-tip intense ...

An improvement in ocular surface health was observed in individuals who underwent IPL therapy for the dermatologic manifestations of rosacea.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9504361/

Therapeutic Efficacy and Safety of Intense Pulsed Light for ...

IPL-MGX was safe and effective for multiple and recurrent chalazia without surgery or curettage by reducing the size of chalazion and improving lid margin ...

7.

nature.com

nature.com/articles/s41598-023-39332-x

Novel treatment of chalazion using light-guided-tip intense ...

An improvement in ocular surface health was observed in individuals who underwent IPL therapy for the dermatologic manifestations of rosacea.

8.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1286159/full

Therapeutic efficacy of optimal pulse technology in the ...

Following the first OPT treatment, a reduction in the chalazion size was observed in 17 patients (73.91%). One patient was completely cured, and ...