Chalazion
Conditions
Brief summary
To study the effectiveness and safety of IPL treatment for Chalazion
Detailed 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
Interventions
DEVICEOptiLIGHT
three IPL or sham treatment in 1 week interval followed by 1 follow-up 4 weeks after the last treatment
Sponsors
Lumenis Be Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group | 4 weeks after the last treatment | the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in lesion size in both groups | 4 weeks after the last treatment | measuring the lesion size using a millimeter ruler |
| Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups | 4 weeks after last treatment | measuring the time that takes for a reduction of at least 80% in lesion size |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Throughout the study and up to 4 weeks after the last treatment | Incidence and type of adverse events |
| Pain/Discomfort | day 0, day 7, day 14 | Pain/discomfort will be self-reported with a visual analog scale (0 to 10), with 0 representing no pain/discomfort and 10 representing intolerable pain/discomfort. |
| modified Meibomian Gland Score | 4 weeks after the last treatment | 15 Meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modified Meibomian Gland Score means that the functionality of Meibomian glands improved, and that the condition of the patient improved. |
| Biomicroscopy | 4 weeks after the last treatment | Eyelid appearance will be assessed with biomicroscopy at the slit lamp |
| satisfaction level | 4 weeks after the last treatment | subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed). |
| IOP | 4 weeks after the last treatment | intra ocular pressure using tonometer |
| Teat Breakup time | 4 weeks after the last treatment | Time between full blink and first appearance of a break in a fluorescein-stained eye |
| BCVA | 4 weeks after the last treatment | Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness) |
Countries
United States
Outcome results
None listed