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

Lumenis Be Ltd.4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chalazion

Interventions

OptiLIGHTDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion 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 Exclusion Criteria: * 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

Locations (2)

Manhattan Face and Eye clinic

New York, New York, United States

Periman Eye Institute

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Percentage change from baseline in lesion size in both groups

measuring the lesion size using a millimeter ruler

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

Data from ClinicalTrials.gov

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