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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Angela Chang, University of Miami
ClinicalTrials.gov Identifier:
NCT01917539
First received: July 19, 2013
Last updated: May 10, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Meibomian Gland Dysfunction
Dry Eye Syndrome
Device: Cutera Xeo Platform-Limelight
Device: Sciton BroadBand Light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Anatomical improvement of the meibomian glands and their secretions. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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, meibography 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), meibography by % of meibomian glands that can be transilluminated, expressibility/consistency (proprietary score on scale of 1-4) will be measured.



Estimated Enrollment: 140
Study Start Date: June 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Pre-existing dry eye treatment + 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: Sciton BroadBand Light
Experimental: Pre-existing dry eye treatment + 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: Cutera Xeo Platform-Limelight Device: Sciton BroadBand Light

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917539

Contacts
Contact: Bradford Lee, MD 808-352-5666 blee@post.harvard.edu
Contact: Angela Chang, BS 310-567-0086 AChang2@med.miami.edu

Locations
United States, Florida
University of Miami Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Angela Chang, BS    310-567-0086    AChang2@med.miami.edu   
Principal Investigator: Wendy Lee, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Wendy Lee, MD University of Miami Bascom Palmer Eye Institute
  More Information

No publications provided

Responsible Party: Angela Chang, Study Coordinator, University of Miami
ClinicalTrials.gov Identifier: NCT01917539     History of Changes
Other Study ID Numbers: 20120140
Study First Received: July 19, 2013
Last Updated: May 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014