Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Lumenis Be Ltd.
Summary
To study the effectiveness and safety of IPL treatment for Chalazion
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 scr…
Interventions
- DeviceSham IPL
Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
- DeviceActive IPL
Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
Locations (2)
- Manhattan Face and Eye clinicNew York, New York
- Periman Eye InstituteSeattle, Washington