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identification of several protocol deviations that may affect the primary outcome accuracy
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | subjects in the study arm will receive active IPL treatment |
|
| Control arm | Sham Comparator | subjects in the control arm will receive sham IPL treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiLIGHT | Device | three IPL or sham treatment in 1 week interval followed by 1 follow-up 4 weeks after the last treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in lesion size in both groups | measuring the lesion size using a millimeter ruler | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| modified Meibomian Gland Score | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Chelnis, MD | Manhattan Face and Eye | Principal Investigator |
| Laura Periman, MD | Periman Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Face and Eye clinic | New York | New York | 10019 | United States | ||
| Periman Eye Institute |
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| ID | Term |
|---|---|
| D017043 | Chalazion |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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measuring the time that takes for a reduction of at least 80% in lesion size
| 4 weeks after last treatment |
| 4 weeks after the last treatment |
| Teat Breakup time | Time between full blink and first appearance of a break in a fluorescein-stained eye | 4 weeks after the last treatment |
| BCVA | 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) | 4 weeks after the last treatment |
| Adverse events | Incidence and type of adverse events | Throughout the study and up to 4 weeks after the last treatment |
| Pain/Discomfort | 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. | day 0, day 7, day 14 |
| IOP | intra ocular pressure using tonometer | 4 weeks after the last treatment |
| Biomicroscopy | Eyelid appearance will be assessed with biomicroscopy at the slit lamp | 4 weeks after the last treatment |
| satisfaction level | subject will fill out a satisfaction questionnaire (very satisfied/satisfied/neutral/disappointed/very disappointed). | 4 weeks after the last treatment |
| Seattle |
| Washington |
| 98119 |
| United States |