Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Toyos Clinic
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Non-invasive Tear Break up Time (TBUT)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Upper eyelid meibomian gland dysfunction
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
Intervention: intense pulsed light (Device)
Outcomes
Primary Outcomes
Non-invasive Tear Break up Time (TBUT)
Time Frame: 2 weeks
average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up
Secondary Outcomes
- Measure of Visual Analog Scale Pain(2 weeks)
- Measure of Visual Analog Scale Pain Over Last 24 Hours(24 hours)
- Ocular Discomfort Frequency Assessment on Visual Analog Scale(24 hours)