Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Stopped early · Not applicable · Has a placebo group
Conditions studied: Chalazion
In brief
To study the effectiveness and safety of IPL treatment for Chalazion
Key facts
- Study ID
- NCT07039461
- Run by
- Lumenis Be Ltd.
- People needed
- 4
- Starts
- 2025-09-12
- Expected to finish
- 2025-12-24
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify 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 qualify 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
Where it is running
- Manhattan Face and Eye clinic — New York, New York, United States
- Periman Eye Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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