Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Upper eyelid treatment has not been used with previously described methods of treatment of dry eye disease using intense pulsed light therapy because the upper lids disease was typically not as advanced as lower lid and because direct treatment of the upper lid was not felt to be necessary as each light pulse extended over the entire periorbita even when concentrated on the lower lid.

Detailed Description
-----------------
Dry eye disease is an under-diagnosed and growing problem. Intense pulsed light has been a proven method of improving the signs and symptoms of meibomian gland dysfunction including lid margin vascularity, meibum viscosity, OSDI mean score and tear break up. This study looks at the safety and effect of treatment of upper lids only to evaluate the safety and efficacy of direct upper lid treatment on the signs and symptoms of dry eye.

Official Title
-----------------
Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: intense pulsed light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects older than 18 cloudy or inspissated meibomian glands in both upper lids ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride. Exclusion Criteria: Patients with eyelid abnormalities intense pulsed light treatment within the past year. Patients on oral retinoids, patients undergoing intraocular surgery within the past year, patients with uncontrolled ocular disease, Fitzpatrick skin type V or VI, neuro-paralysis in the planned treatment area in the past 6 months, pre-cancerous lesions in the planned treatment area. New topical eye treatments, previous expression of meibomian glands, legally blind in one eye.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patient were enrolled in the study if they had visible signs of upper lid meibomian gland dysfunction and persistent dry eye symptoms and pain despite treatment with conservative dry eye therapies.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper eyelid meibomian gland dysfunction<br>Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments | Device: intense pulsed light<br>* Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive Tear Break up Time (TBUT) | average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Visual Analog Scale Pain Over Last 24 Hours | measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome) | 24 hours | 
| Ocular Discomfort Frequency Assessment on Visual Analog Scale | scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes | 24 hours | 
| Measure of Visual Analog Scale Pain | measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome) | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meibomian gland dysfunction