Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lumenis Be Ltd.
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
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
