Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients With Graves Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in tear film stability (NIBUT and FBUT) from baseline during the treatment and in the follow-up period in patients with Graves' ophthalmopathy who undergo low-level light therapy (LLLT)
研究概览
简要总结
This prospective, interventional, randomized, controlled, double-blind clinical study evaluates the effect of Low-Level Light Therapy (LLLT) delivered by a polychromatic periocular mask (Eye-light®️) versus a sham device in adults with dry eye disease (DED) associated with Graves' ophthalmopathy, refractory to conventional topical treatment. The LLLT protocol applies photobiomodulation to eyelid and periocular tissues to support meibomian gland function and reduce tear inflammatory biomarkers. The primary endpoint is the change in tear film stability measured by Non-Invasive Tear Break-Up Time (NIBUT) and Fluorescein Tear Break-Up Time (FBUT). Secondary outcomes include symptom scores (OSDI), Schirmer I test, tear osmolarity, ocular surface staining scales, automated conjunctival hyperemia, blink analysis, meibomian gland morphology (meibography/meiboscale), tear inflammatory biomarkers, and safety/tolerability.
详细描述
This randomized, single-masked, parallel-group clinical trial was conducted to evaluate the efficacy and safety of low-level light therapy (LLLT) in the management of dry eye disease (DED) in patients diagnosed with Graves Ophthalmopathy. The study was carried out at the Department of Ophthalmology of Clinical Hospital CF Iaşi, Romania, University of Medicine and Pharmacy "Grigore T. Popa" (Iași, Romania), in accordance with the Declaration of Helsinki and ICH-GCP guidelines.
Dry eye disease is a multifactorial disorder characterized by tear film instability and ocular surface inflammation. Patients with Graves' ophthalmopathy often experience a severe form of dry eye that is resistant to conventional topical treatments, resulting in a need of finding new therapies to stabilize the tear-film.
LLLT is a non-invasive photobiomodulation technique that delivers low-intensity, polychromatic red and near-infrared light to target mitochondrial cytochromes and promote cellular activity. Its application in ophthalmology has shown potential to improve meibomian gland function, enhance tear film stability, and downregulate inflammatory cytokines on the ocular surface. However, its utility in patient with diagnosed DED associated with Graves Ophthalmopathy has not been formally evaluated.
Eligible participants included consecutive adults (≥18 years) diagnosed with DED associated with Graves Ophthalmopathy that are refractory to conventional dry eye treatments. Key exclusion criteria were pregnant or breastfeeding patients, uncontrolled systemic disease (other than Graves Disease), use of general corticosteroids in the last 6 months, ocular and orbital surgery in the last 6 months, use of contact lenses in the last month and any active ocular infection or allergy.
Eligible participants were randomly assigned to each the active low-level light treatment group or the sham-control group with the Eye-light unit (Espansione Group Ltd, Funo, Italy). Randomization was performed using a computerized allocation sequence (http://www.sealedenvelope.com). Allocation concealment was ensured through sequentially numbered, opaque, sealed envelopes. Both participants and investigators responsible for clinical evaluations remained unaware of group assignment throughout the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with dry eye disease, particularly associated with Graves' ophthalmopathy.
- •Refractory to conventional dry eye treatments (e.g., artificial tears, cyclosporine, corticosteroid eye drops).
- •Adult patients (over 18 years old).
排除标准
- •Pregnant or breastfeeding.
- •Uncontrolled systemic diseases (other than Graves' disease).
- •Use of general corticosteroids in the last 6 months.
- •Ocular or orbital surgery in the last 6 months.
- •Use of contact lenses within the last week.
- •Active ocular infection or allergy.
结局指标
主要结局
Changes in tear film stability (NIBUT and FBUT) from baseline during the treatment and in the follow-up period in patients with Graves' ophthalmopathy who undergo low-level light therapy (LLLT)
时间窗: Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.
Noninvasive Tear Break-Up Time (NIBUT) is an eye test measuring the stability of the tear film without using dye (fluorescein), making it more accurate than standard tests. It determines how long the tear film stays intact before breaking, with results typically indicating dry eye if the time is under 10 seconds. Fluorescein Breakup Time (FBUT) is a diagnostic test measuring the time (in seconds) between the last blink and the appearance of the first dry spot or break in the tear film. Both of these measurements were assessed objectively on average of three repeats in order to obtain the average value using the DEA 520 Dry Eye Analyzer; Moptim / Shenzhen Certainn Technology Co., Ltd., China. The primary outcome is the change in the tear film stability from baseline to 3 months after the final treatment, comparing the LLLT group to the sham group.
次要结局
- Ocular Surface Disease Index (OSDI)(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Schirmer I Test(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Tear osmolarity(Before first mask session, at 1 month and 3 months follow ups after the final treatment.)
- Tear meniscus height(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Meibography graded with the meiboscale for upper and lower eyelids(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Blinking rate(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Fluorescein corneal staining(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Tear Inflammatory and Reparative Biomarkers(At baseline and 3 months after the last treatment.)
- Lipid layer pattern grading(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Exophthalmometry(At baseline (before treatment), 1 month and 3 months follow up.)
- Automated hyperemia assessment(Before first mask session, and weekly before each treatment to the final treatment, at 1 month, 2 months and 3 months follow ups after the final treatment.)
- Clinical Activity Score (CAS)(At baseline (before treatment), 1 month and 3 months follow up.)
研究者
Timofte Zorila Mihaela Madalina
Principal Investigator
Grigore T. Popa University of Medicine and Pharmacy