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

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ClinicalTrials.gov Identifier: NCT03658811
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Toyos Clinic

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.

Condition or disease Intervention/treatment Phase
Dry Eye Device: intense pulsed light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: 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
Device: intense pulsed light
Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658811


Locations
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United States, Tennessee
Toyos Clinic
Nashville, Tennessee, United States, 37027
Sponsors and Collaborators
Toyos Clinic
  Study Documents (Full-Text)

Documents provided by Toyos Clinic:

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Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03658811     History of Changes
Other Study ID Numbers: TCLum-001
First Posted: September 5, 2018    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Excel spreadsheet with data but no identifying characteristics could be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Toyos Clinic:
meibomian gland dysfunction

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases