An interventional study of Sham IPL and Active IPL in Chalazion, sponsored by Lumenis Be Ltd.. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
To study the effectiveness and safety of IPL treatment for Chalazion
The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
sebaceous carcinoma and basal cell carcinoma
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects in the study arm will receive active IPL treatment
Device: Active IPL
subjects in the control arm will receive sham IPL treatment
Device: Sham IPL
Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group
the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit
Time frame: 4 weeks after the last treatment
Percentage change from baseline in lesion size in both groups
measuring the lesion size using a millimeter caliper
Time frame: 4 weeks after the last treatment
Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups
measuring the time that takes for a reduction of at least 80% in lesion size
Time frame: 4 weeks after last treatment
modified Meibomian Gland Score
15 Meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modified Meibomian Gland Score means that the functionality of Meibomian glands improved, and that the condition of the patient improved.
Time frame: 4 weeks after the last treatment
Teat Breakup time
Time between full blink and first appearance of a break in a fluorescein-stained eye
Time frame: 4 weeks after the last treatment
BCVA
Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness)
Time frame: 4 weeks after the last treatment
Adverse events
Incidence and type of adverse events
Time frame: up to 7 weeks
IOP
intra ocular pressure using tonometer
Time frame: 4 weeks after the last treatment
Biomicroscopy
Eyelid appearance will be assessed with biomicroscopy at the slit lamp
Time frame: 4 weeks after the last treatment
satisfaction level
subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed).
Time frame: 4 weeks after the last treatment
Pain/Discomfort
Pain/discomfort will be self-reported with a visual analog scale (0 to 10), with 0 representing no pain/discomfort and 10 representing intolerable pain/discomfort.
Time frame: immediately after the treatment
Start is estimated for Feb 2026; primary completion for Dec 2026, 10 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Chalazion