Dry Eye Syndromes, Meibomian Gland Dysfunction
Conditions
Keywords
Dry eye, Blepharitis, Meibomian gland dysfunction, intense pulsed light
Brief summary
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
Detailed description
Broadband light (BBL) is a widely used treatment for improvement of inflammatory dermatologic conditions such as acne and rosacea, and may have similar therapeutic benefits on the treatment of dry eye disease by targeting inflammation of the eyelids. The investigators propose a prospective study to determine the safety and efficacy of BBL treatment on patients with dry eye disease and meibomian gland dysfunction. Each participant will have three treatments of BBL at monthly intervals to the cheek and periorbital area with subsequent follow up. Measured endpoints will include signs and symptoms of dry eye control including full ophthalmic exam, dry eye diagnostic testing, photographs, and standardized questionnaires.
Interventions
DEVICEBroadband Light treatment
While shielding the eyes, multiple passes of broadband light will be applied to the upper cheeks and eyelids after applying topical lidocaine.
DEVICESham broadband light treatment
The light will be occluded on the usual BBL device so that no treatment is delivered but the preparation and procedure will otherwise be the same.
Sponsors
Ophthalmic Surgeons & Consultants of Ohio, Inc.
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be randomized to protocol 1, 2, or sham but will not be aware of their assignment; investigators grading dry eye at baseline and after treatment will not be aware of which protocol the patients underwent.
Intervention model description
Participants will be randomized to three arms: protocol 1, 2, and sham
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Fitzpatrick Skin Type I-V * Must be diagnosed with Dry eye disease (DED) and meibomian gland dysfunction (MGD) * Persistent dry eye signs and or symptoms after at least one prior DED treatment modality
Exclusion criteria
* Prior Intense pulsed light treatment for DED within the past six months * Prior Meibomian gland treatment with a device for DED within the past three months * History of trauma-induced ocular surface disease (thermal burns, chemical burns) * Subject is pregnant * History of seizures * Having significant unprotected sun exposure within the treatment area * Use of Accutane within the last six months * Use of doxycycline in the last 1 month * Allergy to proparacaine or lidocaine * Having active herpes simplex virus infection within the treatment area * Laser eye surgery (LASIK) within the past twelve months * History of abnormal response to sunlight * Having an active medical condition that may affect normal healing * Having active infections or compromised immune system * History of basal cell carcinoma in the treatment area within the past twelve months * History of keloid scar formation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dry eye score | 1 month after last BBL treatment (4 month time-point) | Change in SPEED dry eye disease questionnaire score from baseline to 1 month post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation of dry eye-- Change in fluorescein staining grade | 1 month after last BBL treatment | Change in Fluorescein staining graded with Oxford scale score from baseline to 1 month post-treatment |
| Clinical evaluation of dry eye--Change in tear osmolarity | 1 month after last BBL treatment | Change in tear osmolarity (in milliosm/L) from baseline to 1 month post-treatment |
| Ocular surface/eyelid microbiome data | 1 month after last BBL treatment | genomic analysis of ocular surface flora at baseline compared to 1 month post-treatment |
| Clinical evaluation of dry eye--Change in tear breakup time | 1 month after last BBL treatment | Change in tear break up time (in seconds) from baseline to 1 month post-treatment |
| Clinical evaluation of dry eye--Change in basal tear production | 1 month after last BBL treatment | Change in basal tear production (in millimeters using standardized filter paper) from baseline to 1 month post-treatment |
| Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration | 1 month after last BBL treatment | Change in MMP-9 testing (test is positive for MMP-9 level above 40ng/mL, and negative if below that threshold) from baseline to 1 month post-treatment |
Contacts
Primary ContactSandy Zhang-Nunes, MD
Backup ContactJessica R Chang, MD
Outcome results
None listed