Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Tear Break-up time in seconds, using the standard Fluorescein staining method
研究概览
简要总结
The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.
详细描述
The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments.
The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand and sign an Informed Consent (IC) form
- •18-80 years of age
- •Fitzpatrick skin type 1-4
- •Able and willing to comply with the treatment/follow-up schedule and requirements
- •At least 5 non-atrophied glands on each eye's lower eyelid
- •Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria:
- •Tear break-up time (TBUT) ≤ 10 seconds in both eyes;
- •Meibomian gland (MG) score (using the Abbreviated MGD grading system for clinical trials) ≥ 11 in both eyes
- •Corneal Fluorescein Staining (CFS) score (using the Baylor grading scheme) ≥ 10 in both eyes;
- •Tear Osmolarity ≥ 310 milliosmol/L in both eyes, or a difference higher than 8 milliosmol/L between the two eyes
- •SPEED ≥ 10
- •Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nuvaring and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.
排除标准
- •Contact lens wearer within the past 1 month and throughout the study
- •Recent ocular surgery or eyelid surgery within the past 6 months
- •Neuro-paralysis in the planned treatment area within the past 6 months
- •Other uncontrolled eye disorders affecting the ocular surface
- •Current use of punctal plugs
- •Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
- •Uncontrolled infections or uncontrolled immunosuppressive diseases
- •Subjects who have undergone laser in situ keratomileusis (LASIK) surgery within the past 6 months
- •Diseases in the planned treatment area that could be stimulated by light at 560 nm to 1200 nm (e.g., Herpes simplex 1 and 2, Systemic Lupus erythematosus, porphyria)
- •Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, or St. John's Wort
- •Over exposure to sun within the past 4 weeks, in the judgment of the treating physician
- •Pregnancy and nursing
- •Administration of prescription eye drops for dry eye within the past 48 hours, excluding artificial tears
- •Radiation therapy to the head or neck within the past year, or planned radiation therapy within 8 weeks after completion of all IPL treatments
- •Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy within 8 weeks after completion of all IPL treatments
- •New topical treatments within the area to be treated, or oral therapies within the past 3 months, except over-the-counter acetaminophen-based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment
- •Change in dosage of any systemic medication within the past 3 months
- •Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up within the next 16 weeks
- •Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
- •Declared legally blind in one eye
- •History of migraines, seizures or epilepsy
- •IPL treatment within the past 12 months
- •Lipiflow treatment, or any equivalent treatment, within the past 12 months
- •Expression of the meibomian glands within the past 12 months
结局指标
主要结局
Tear Break-up time in seconds, using the standard Fluorescein staining method
时间窗: from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment
The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film
次要结局
- Corneal fluorescein staining score, using the Baylor Scheme(from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment)
- Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"(from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment)
- Subjective symptoms, using the SPEED questionnaire(from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment)
- Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample(from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment)
- Lipid Layer Thickness in nanometers, using an interferometer(from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment)