Status:
WITHDRAWN
Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome
Lead Sponsor:
University of Miami
Conditions:
Meibomian Gland Dysfunction
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 dysfuncti...
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 regi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01917539
Start Date
June 1 2013
End Date
May 1 2015
Last Update
June 28 2018
Active Locations (1)
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1
University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States, 33136