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临床试验/NCT07229001
NCT07229001Enrolling By Invitation不适用

A Randomized Clinical Trial of Treating Meibomian Gland Disease in a Pediatric Population

Illinois College of Optometry1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
15
试验地点
1
主要终点
MG score

研究概览

简要总结

Dry Eye Disease (DED) is commonly encountered among eye care professionals. DED is a disease of the tears and ocular surface that is multi-factorial resulting in a wide range of symptoms and signs with potentially damaging effects. As technology continues to evolve and as digital devices become more available in social, work environments, and in school settings, patients are increasingly complaining of ocular discomfort and fluctuations in their vision.

In order to diagnose DED which encompasses Meibomian gland dysfunction (MGD), a detailed case history of \patients' symptoms along with imaging to investigate the amount of disease present in their eyes is needed. A customized questionnaire and the Keratograph meibographer will allow for a subjective and objective investigation of dry eye disease in patients. Artificial tears and warm compress are traditional methods used to treat DED. However, many patients continue to have progression of disease. The Marco Equinox Low Level Light Therapy (LLLT) utilizes a LED mask to apply red light to the periorbital and cheekbone regions of the face, which effectively normalizes meibomian gland function. This is a non-invasive treatment of both the upper and lower eyelids, which does not require a gel application. Treatment of both eyes takes approximately 15 minutes. In the clinical studies that have been published, lipid layer interference pattern, non-invasive tear break up time, lissamine green conjunctival staining, Schirmer's test, and upper meibography scores showed significant improvement by 4 weeks after the start of treatment with LLLT. To our knowledge, this has not been studied in the pediatric population, but the disease process is the same. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to traditional treatment (warm compress and artificial tear) only in children.

详细描述

The clinical diagnosis of Dry Eye Disease is often made using a combination of subjective symptoms and clinical signs. During early development of DED, patients may be asymptomatic. If asymptomatic, the diagnosis of DED is only detectable by the presence of clinical signs. Advanced DED can be debilitating as it can lead to multiple complications including increasing the risk of eye infections and destruction of ocular tissue which eventually causes a loss of functional visual acuity1-3.

Symptoms of dry eye may include ocular itching, burning, redness, irritation, soreness and or edema of the eyelids, foreign body sensation, tearing, fluctuating vision, and contact lens intolerance. The signs of ocular surface damage includes staining to the bulbar conjunctiva and cornea, reduced tear-break-up-time, decreased tear production, and decreased tear quaaulity. Several questionnaires have been reviewed5-6 to assess symptoms of ocular surface disease and dry eye. The Ocular Surface Disease Index (OSDI)5 assesses vision-related function, ocular symptoms, and environmental triggers resulting from dry eye where the goal of the Dry Eye Questionnaire 5 (DEQ-5) is to identify patients with keratoconjunctivitis sicca from those without the condition by asking about the frequency of the feeling of eye dryness. This may be more appropriate to use in the pediatric population as they may not be able to identify with the feeling of dryness, but they should be able to understand 'discomfort' or 'uncomfortable'. While not validated in the pediatric population and regardless of their diagnostic sensitivity for dry eye, standardized questionnaires help assess subjective changes of the patient's symptoms in response to treatment.

Meibomian gland dysfunction can result from a variety of factors, including but not limited to incomplete blinking due to the gland not being able to express a clear lipid layer. This can result in inadequate distribution of the lipid component of the tear layer thereby disrupting adherence of the tears to the eye and thus causing patients to experience the common symptom of "dry eyes." 1,3,4 Once atrophy of the gland occurs, the damage cannot be reversed. Therefore, it is crucial for these patients to maintain healthy tear films and meibomian glands so they don't experience a decrease in visual acuity that can interfere with activities of daily life.

There are several factors which have been proposed to decrease the quality the tear layer and affect the viability of the meibomian glands, and they will be assessed during this study via questionnaires. The one of main interest, particularly in the pediatric population is digital device use. Patient usage of digital devices including: handheld tablets, smart phones, laptops, and computers are increasing as new technology develops and as social and work environments adapt to these technological changes. With the increase in usage of digital devices, eye care practitioners have noted an increase in dry eye signs and symptoms. The potential adverse effect of increased digital device usage may interfere with work performance, productivity, and quality of life.7-9

High levels of mild meibomian gland atrophy have been reported in the pediatric population. This may be due to increased digital device use and near demands of schoolwork. Subsequently, we should be examining young patients for meibomian gland atrophy and dysfunction as early as possible as it may have implications for future development of dry eye disease and complications. Artificial tears and warm compress have been the traditional treatments for DED. Recently, LLLT has been confirmed to produced significant improvements in meibomian gland function and symptoms.10 However, it has not been tested in children. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to using warm compress and artificial tear only in children.

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
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • subjects with severe MGD

排除标准

  • i. Thyroid disease ii. Autoimmune disease iii. Diabetes iv. History of ocular surgery other than refractive surgery v. Disfiguring eye trauma vi. Active infections or severe allergic conjunctivitis vii. Currently pregnant or nursing viii. Epilepsy vii.ix. Migraine

结局指标

主要结局

MG score

时间窗: 1 month

atropine score

Change in MG

时间窗: 1 months

atrophy score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Pang

professor

Illinois College of Optometry

研究点 (1)

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