Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: IRPL Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45 |
Device: E>Eye IRPL
Regulated intense pulsed light therapy
|
Active Comparator: Warm compress Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes |
Device: Warm compress
Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Symptoms of dry eye disease [Change between baseline and day 75]
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
- Tear film stability [Change between baseline and day 75]
Change in non-invasive assessed tear film retention time from baseline to end of trial
Secondary Outcome Measures
- Eye redness [Change between baseline and day 75]
Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)
- Meibomian gland patency [Change between baseline and day 75]
Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)
- Tear volume [Change between baseline and day 75]
Change in tear meniscus height measured in millimeters
- Lipid layer thickness [Change between baseline and day 75]
Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes)
Eligibility Criteria
Criteria
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:
-
OSDI score >13 and
-
NITBUT <= 10sec
Exclusion Criteria:
-
No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
-
Patients with greater 75% meibomian gland loss
-
Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
-
Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
-
Artificial tear usage within 2 hours prior to study testing
-
Other invasive ocular diagnostic testing within 2 hours prior to study testing
-
Eye makeup present on the eye lid within 10 minutes prior to study testing
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Market Mall Eye Clinic - Calgary, AB | Calgary | Alberta | Canada | AB T3A 0E2 |
Sponsors and Collaborators
- Aston University
Investigators
- Principal Investigator: James Wolffsohn, PhD, Aston University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Eeye03182021