Broadband Light for the Treatment of Dry Eye Disease and Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in dry eye score
研究概览
简要总结
The investigators will be evaluating the use of broadband light in Dry Eye and Meibomian Gland Dysfunction.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Protocol 1--420 and 560nm wavelengths
Broadband light treatment Patients will be treated with BBL with 420nm wavelength filter followed by 560nm wavelength filter to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last BBL treatment.
干预措施: Broadband Light treatment (Device)
Protocol 2--560nm wavelength
Broadband Light treatment Patients will be treated with BBL with 560nm wavelength filter to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last BBL treatment.
干预措施: Broadband Light treatment (Device)
Sham
Sham Broadband Light Treatment Patients will undergo the same preparation and procedure as for BBL treatment but the light source will be occluded. Patients will be treated with sham to malar and periorbital areas once monthly for 3 months. Dry eye evaluation consisting of clinical testing as well as quality of life questionnaires will be performed at baseline and after the last sham treatment.
干预措施: Sham broadband light treatment (Device)
结局指标
主要结局
Change in dry eye score
时间窗: 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
次要结局
- Ocular surface/eyelid microbiome data(1 month after last BBL treatment)
- Clinical evaluation of dry eye-- Change in fluorescein staining grade(1 month after last BBL treatment)
- Clinical evaluation of dry eye--Change in tear osmolarity(1 month after last BBL treatment)
- Clinical evaluation of dry eye--Change in tear breakup time(1 month after last BBL treatment)
- Clinical evaluation of dry eye--Change in basal tear production(1 month after last BBL treatment)
- Clinical evaluation of dry eye--Change in Matrix metalloproteinase-9 (MMP-9) presence in significant concentration(1 month after last BBL treatment)
研究者
Sandy Zhang-Nunes
Director of Oculoplastics, USC Roski Eye Institute
University of Southern California