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

Toyos Clinic19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye

Interventions

intense pulsed lightDEVICE

Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Toyos Clinic

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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