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NCT Number: NCT07405138

Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion

To study the effectiveness and safety of IPL treatment for Chalazion

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Key information

Conditions

Chalazion Cysts Eye Diseases Eyelid Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manhattan Face and Eye clinic, New York, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is able to read, understand, and sign an Informed Consent Form (ICF)
  • 18 years of age or older
  • Clinical diagnosis of chalazion in the inflammatory stage
  • Subject is willing to comply with all study procedures-

Exclusion criteria

  • Concurrent eyelid infection
  • Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
  • Recurring Chalazion
  • Floppy eyelid syndrome
  • Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening
  • Ocular surgery within 3 months prior to screening
  • Current diagnosis of malignant tumors in the affected eyelid, including:

sebaceous carcinoma and basal cell carcinoma

  • Laser Assisted In Situ Keratomileusis (LASIK)/Small Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening
  • Radial Keratotomy (RK) surgery
  • Recent ocular trauma, within 3 months prior to screening
  • Pre-cancerous lesions or skin cancer in the planned treatment area
  • Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
  • Uncontrolled infections or uncontrolled immunosuppressive diseases
  • Best corrected visual acuity worse than 20/200 in either eye
  • Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)
  • Within 1 week prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
  • Active sun burn in the treatment area
  • Anterior chamber inflammation
  • Corneal edema
  • Any condition revealed w

Treatment and study plan

Sham IPL

Device

Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

Active IPL

Device

Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

Primary outcomes

  1. The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group

    Time frame: 4 weeks after the last treatment

    the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit

Secondary outcomes

  1. Percentage change from baseline in lesion size in both groups

    Time frame: 4 weeks after the last treatment

    measuring the lesion size using a millimeter caliper

  2. Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups

    Time frame: 4 weeks after last treatment

    measuring the time that takes for a reduction of at least 80% in lesion size

Other outcomes

  1. modified Meibomian Gland Score

    Time frame: 4 weeks after the last treatment

    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.

  2. Teat Breakup time

    Time frame: 4 weeks after the last treatment

    Time between full blink and first appearance of a break in a fluorescein-stained eye

  3. BCVA

    Time frame: 4 weeks after the last treatment

    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)

  4. Adverse events

    Time frame: up to 7 weeks

    Incidence and type of adverse events

  5. IOP

    Time frame: 4 weeks after the last treatment

    intra ocular pressure using tonometer

  6. Biomicroscopy

    Time frame: 4 weeks after the last treatment

    Eyelid appearance will be assessed with biomicroscopy at the slit lamp

  7. satisfaction level

    Time frame: 4 weeks after the last treatment

    subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed).

  8. Pain/Discomfort

    Time frame: immediately after the treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haya Hamza, Bsc

CONTACT

[email protected]

+972527493696

Sponsors and collaborators

Lead sponsor

Lumenis Be Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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