Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome

Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e. redness, burning sensation) and particularly if not used properly, the potential to cause burns, blistering, scarring, and pigmentary changes.

Study Overview

• Status: Withdrawn
• Conditions: Meibomian Gland Dysfunction; Dry Eye Syndrome
• Intervention / Treatment: Device: Sham Treatment; Device: Pulsed Light Therapy

Detailed Description

Group 1: pre-existing dry eye treatment regimen + sham light treatment. Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.

Group 2: pre-existing dry eye treatment regimen + pulsed light therapy (PLT)

Subjects will be recruited from the outpatient clinics at Bascom Palmer Eye Institute, will have a chief complaint of dry eyes, and will have to meet all inclusion/exclusion criteria. Subjects will be randomized via computerassisted random number generation to Group 1 or 2. All subjects will undergo baseline evaluation for DES including a standardized questionnaire about symptoms of dry eyes (takes about 5 minutes to complete and assesses the presence and severity of dry eye symptoms), various testing on the properties and composition of the tear film, grading of changes related to dry eye seen on the surface of the eye, and grading of the oil glands on the eyelid (meibomian glands) and their secretions. Primary outcomes will be anatomical improvement of the meibomian glands and their secretions.

Subjects in Group 1 will continue their pre-existing dry eye treatment regimen and receive sham light treatment, whereas subjects in Group 2 will continue their pre-existing dry eye treatment regimen and receive PLT. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.

The PLT devices are FDA approved for the treatment of rosacea in the periocular/facial region, and having facial rosacea is one of the inclusion criteria for this study. This is the indication for treatment with PLT. The devices are not FDA-approved for the treatment of DES, although this is something we will be looking at as one of our main outcomes.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater or equal to 18 y/o
• Patients presenting to academic referral center for DES
• Diagnosis of mild to moderate DES with meibomian gland dysfunction and ocular rosacea, based on evaluation of meibomian glands (MG), MG secretions, and other factors
• Facial rosacea
• Patients must not have started any new medications within the past 1 month
• Patients should not be using warm compresses or lid scrubs more than 1-2 times in the previous 2 weeks
• Symptomatic changes in DES

Exclusion Criteria:

• Age < 18
• History of inflammatory DES (e.g. Sjogren's, rheumatoid arthritis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid)
• History of trauma-induced ocular surface disease (thermal burns, chemical burns)
• Severe DES
• Pregnant women
• H/o seizures
• Significant unprotected sun exposure or use of tanning beds or creams in treated area (must be discontinued at least 2 weeks prior to treatment, during treatment course, and 2 weeks after last treatment)
• Use of Accutane, anti-coagulants, or St. John's Wort
• Active infections/immunosuppression
• Herpes 1 or 2 within the treatment area
• Patients who have undergone LASIK surgery within the past 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Treatment; Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.	Device: Sham Treatment; Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.
Experimental: Pulsed Light Therapy; All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.	Device: Pulsed Light Therapy; Light treatment will consist of applying eye shields used for PLT, applying the skin gel to the facial region, and applying the probe with application of pulsed light therapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical improvement of the meibomian glands and their secretions.	We are looking at subjective changes in DES symptomatology based on the OSDI questionnaire score. We are also looking at objective changes in examination findings based on the tear film properties (TBUT, Schirmer), staining patterns of the ocular surface using fluor. and LG dyes, characteristics of the meibomian glands and lid margin (e.g. telangiectasias, notching, myelography by transillumination, etc), as well as the meibum secretions (e.g. expressibility, and consistency). Change in baseline for OSDI, TBUT in seconds, Schirmer testing in mm, staining pattern score (standardized proprietary score on a scale of 1-4), myelography by % of meibomian glands that can be transilluminated, expressibility/consistency (proprietary score on scale of 1-4) will be measured.	3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Wendy Lee, MD, University of Miami Bascom Palmer Eye Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: 20120140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No