RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To study the effectiveness and safety of IPL treatment for Chalazion

Official Title

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

Quick Facts

Study Start:2025-09-12

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07039461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is able to read, understand, and sign an Informed Consent Form (ICF) * 18 years of age or older * Clinical diagnosis of acute chalazion, present for a maximum of 4 weeks * Subject is willing to comply with all study procedures	* Subjects who underwent IPL treatment less than 6 months prior to screening * Concurrent eyelid infection, which to the opinion of the study investigator is not related to the chalazion * Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study * Chronic Chalazion * 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 3 months 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 whereby the investigator deems the subject inappropriate for this study

Inclusion Criteria

Exclusion Criteria

* Subject is able to read, understand, and sign an Informed Consent Form (ICF)
* 18 years of age or older
* Clinical diagnosis of acute chalazion, present for a maximum of 4 weeks
* Subject is willing to comply with all study procedures

* Subjects who underwent IPL treatment less than 6 months prior to screening
* Concurrent eyelid infection, which to the opinion of the study investigator is not related to the chalazion
* Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
* Chronic Chalazion
* 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 3 months 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 whereby the investigator deems the subject inappropriate for this study

Contacts and Locations

Study Contact

Haya Hamza, Bsc

CONTACT

+972527493696

haya.hamza@lumenis.com

Principal Investigator

James Chelnis, MD

PRINCIPAL_INVESTIGATOR

Manhattan Face and Eye

Laura Periman, MD

PRINCIPAL_INVESTIGATOR

Periman Eye Institute

Study Locations (Sites)

Manhattan Face and Eye clinic

New York, New York, 10019

United States

Periman Eye Institute

Seattle, Washington, 98119

United States

Collaborators and Investigators

Sponsor: Lumenis Be Ltd.

James Chelnis, MD, PRINCIPAL_INVESTIGATOR, Manhattan Face and Eye
Laura Periman, MD, PRINCIPAL_INVESTIGATOR, Periman Eye Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-12

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-09-12

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Chalazion