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

To study the effectiveness and safety of IPL treatment for Chalazion

Study Overview

• Status: Not yet recruiting
• Conditions: Chalazion
• Intervention / Treatment: Device: Active IPL; Device: Sham IPL

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haya Hamza, Bsc; Phone Number: +972527493696; Email: haya.hamza@lumenis.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Manhattan Face and Eye clinic
      • Contact: James Chelnis, MD; Email: drchelnis@manhattanfaceandeye.com
      • Principal Investigator: James Chelnis, MD
  • Washington
    • Seattle, Washington, United States, 98119
      • Periman Eye Institute
      • Contact: AnaLucia Clarkson; Phone Number: +1 (206) 3470821; Email: concierge@perimaneyeinstitute.com
      • Contact: Laura Periman, MD; Phone Number: 206-347-0821; Email: ClinicalTrials@perimaneyeinstitute.com
      • Principal Investigator: Laura Periman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control arm; 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
Experimental: study arm; subjects in the study arm will receive active IPL treatment	Device: Active IPL; Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks after the last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks after last treatment
Percentage change from baseline in lesion size in both groups	measuring the lesion size using a millimeter caliper	4 weeks after the last treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teat Breakup time	Time between full blink and first appearance of a break in a fluorescein-stained eye	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)	4 weeks after the last treatment
IOP	intra ocular pressure using tonometer	4 weeks after the last treatment
Biomicroscopy	Eyelid appearance will be assessed with biomicroscopy at the slit lamp	4 weeks after the last treatment
satisfaction level	subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed).	4 weeks after the 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.	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.	immediately after the treatment
Adverse events	Incidence and type of adverse events	up to 7 weeks

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: James Chelnis, MD, Manhattan Face and Eye clinic; Principal Investigator: Laura Periman, Periman Eye Institute

Study record dates

Study Major Dates

• Study Start (Estimated): February 4, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Eye Diseases; Cysts; Eyelid Diseases; Chalazion
• Other Study ID Numbers: LUM-VBU-IPL-26-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No