跳至主要内容
临床试验/NCT03194698
NCT03194698已完成不适用

Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
20
试验地点
2
主要终点
Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score

研究概览

简要总结

Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation.

Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms.

Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX.

Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL.

Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools.

We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study.

Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score

时间窗: baseline, 3 months

Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

次要结局

  • Change in Meibomian Glands Open - Right Lower Lid(baseline, 3 months)
  • Change in Meibomian Glands Open - Left Lower Lid(3 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne F. Shen, M.D.

Chair, Department of Ophthalmology - Arizona

Mayo Clinic

研究点 (2)

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