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Completed

NCT Number: NCT03658811

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toyos Clinic

Nashville, Tennessee, 37027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intense Pulsed Light

Device

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

Primary outcomes

  1. 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

  1. Measure of Visual Analog Scale Pain Over Last 24 Hours

    Time frame: 24 hours

    measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)

  2. Ocular Discomfort Frequency Assessment on Visual Analog Scale

    Time frame: 24 hours

    scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes

  3. Measure of Visual Analog Scale Pain

    Time frame: 2 weeks

    measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)

Sponsors and collaborators

Lead sponsor

Toyos Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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