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This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress
E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.
The study will monitor the change in symptoms and signs of dry eye at each visit.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRPL | Experimental | Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45 |
|
| Warm compress | Active Comparator | Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E>Eye IRPL | Device | Regulated intense pulsed light therapy |
| |
| Warm compress |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of dry eye disease | Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial | Change between baseline and day 75 |
| Tear film stability | Change in non-invasive assessed tear film retention time from baseline to end of trial | Change between baseline and day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Eye redness | Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better) | Change between baseline and day 75 |
| Meibomian gland patency | Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale) |
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Inclusion Criteria:
Willing and able to provide informed consent and participate in the required study visit
Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Wolffsohn, PhD | Aston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Market Mall Eye Clinic - Calgary, AB | Calgary | Alberta | AB T3A 0E2 | Canada |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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Randomized allocation between treatments
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Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
| Device |
Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes |
|
|
| Change between baseline and day 75 |
| Tear volume | Change in tear meniscus height measured in millimeters | Change between baseline and day 75 |
| Lipid layer thickness | Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes) | Change between baseline and day 75 |