Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome
| Status: | Withdrawn |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2018 |
| Start Date: | June 2013 |
| End Date: | May 2015 |
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.
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.
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.
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.
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
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