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临床试验/NCT05577910
NCT05577910进行中(未招募)不适用

Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) Therapies for Meibomian Gland Dysfunction- a Randomized, Assessor-masked, Active-controlled Clinical Trial

Chinese University of Hong Kong4 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
360
试验地点
4
主要终点
Change from baseline Tear film breakup time (TFBUT) at 6 months

研究概览

简要总结

Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited with low compliance. This study aims to (1)compare the efficacy and safety of two emerging alternatives- vectored thermal pulsation(VTP) or intense pulsed light and meibomian gland expression(IPL + MGX) with EW therapy; (2)identify factors predicting outcome.

This is a prospective, randomized, assessor-masked, active-controlled clinical study. 360 participants (360 study eyes) with mild-to-moderate MGD will be randomized by minimization into three arms equally, receiving either VTP by TearScience-LipiFlow® Thermal Pulsation System (month 0), IPL by Lumenis®️M22 with MGX (month 0, 1, 2, 3) or EW (twice daily). Lubricating eye drops (3% Hypromellose) will be provided for all subjects throughout the study period(15 months). Tear film breakup time will be assessed as primary outcome at month 6, 15. Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes and treatment-related complications will be conducted at baseline and each follow-up visit by masked observers at baseline and eight follow-up evaluation (month 0, 1, 2, 3, 4, 6, 9, 12, 15).

详细描述

Dry eye disease (DED) is an emerging, under-recognized and under-treated epidemic of the 21st century. It is one of the commonest reasons seeking eye consultation worldwide. Depending on the diagnostic criteria, geographic location and population concerned, prevalence of DED ranges from 30 to over 50% in the Asia Pacific regions compared to around 5-10% in the United States. Up to 90% of DED is closely associated with meibomian gland dysfunction (MGD), a chronic and progressive condition characterized by terminal duct obstruction, qualitative and/or quantitative changes in the glandular secretions (meibum) which causes tear instability by increasing tear evaporation and subsequently increased tear osmolarity, ocular surface inflammation, epithelial damage and ocular surface disease. Studies suggest that MGD affects between 5-20 % of Caucasians and over 60% of Asians populations.

Conventional treatments for MGD including self-administered eyelid hygiene, eyelid warm compress therapy (EW), artificial tears, including lipid-containing lubricants are limited in their efficacies for moderate to advanced disease. Prescription medications (topical steroids, topical and oral antibiotics, topical immunomodulatory agents e.g. cyclosporine and oral omega-3 essential fatty acids) have demonstrated efficacies in improving symptoms and signs of MGD; however side-effects including preservative-related adverse events, development of antibiotic resistance, cost, accessibility, off-label use, and the need for ongoing treatments often limit their long-term use.

Despite the described range of available options, management for MGDs is often considered unsatisfactory and frustrating by clinicians and patients. Compliance to long-term, home-based self-administered therapies is known to be suboptimal while practitioner-administered treatment including meibomian gland expression (MGX) provides transient relief.

Intense pulsed light (IPL) therapy is widely used in cosmetic dermatology as well as therapeutically for a wide range of skin conditions with favourable efficacy and tolerability. Concurrent MGD improvements were observed serendipitously in patients undergoing IPL for rosacea. With growing interest in combining IPL+MGX as practitioner-administered physical therapy for MGD, recent review and meta-analysis showed its effectiveness and safety while calling to investigate its effect beyond 6 months after the last IPL treatment.

Vectored thermal pulsation (VTP) is approved by FDA as another practitioner-administered physical therapy for MGD. The device covers both the cutaneous and mucosal surfaces of the eyelids; the rear portion of the device provides heat to the MG, and the front portion gives mechanical stimulation to the eyelid skin. It evacuates the MG of the upper and lower eyelids simultaneously with minimal discomfort while protecting the cornea, rendering the experience for patients generally favorable. Recent meta-analysis showed that a single 12-minute VTP was more efficacious than EW in treating MGD.

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
Single (Outcomes Assessor)

盲法说明

Unmasked trial coordinators will ensure masking by reminding and accompanying each patient before and during visits. Treatment related complications will be evaluated by all participants in a standard datasheet regardless of group assignment. Follow-up investigators will be asked if they know each participant's group assignment at each visit and why.

入排标准

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

入选标准

  • ≥18 years of age with no upper age limit;
  • Agree to attend follow-up visits and comply to treatment regimen;
  • Symptomatic dry eye TFBUT (average of 3 times) ≤ 5 seconds and OSDI ≥ 13;
  • Mild to moderate (level 3-4) MGD on at least one eye;
  • Fitzpatrick skin type 1-4.

排除标准

  • Contact lens wear 3 months before or during the study period;
  • Use of topical (including anti-glaucomatous, cyclosporin, antibiotics) or systemic medication known to affect (worsen or improve) MGD 3 months before or during the study period;
  • Major systemic (e.g. Sjogren's syndrome), dermatologic (e.g. Rosacea) known to affect MGD or ocular conditions (including thyroid eye disease, recurrent conjunctivitis, ocular allergies);
  • Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period;
  • History of vision correction surgery or plan to undergo the procedure during the study period;
  • Dermatological treatment (including chemical peeling, laser, IPL or energy device in the periocular and facial region) 6 months before or during the study period;
  • Contraindications to IPL therapy (including recent sun-burn, photosensitivity, active or pigmented skin lesions, cancer, implants, tattoos, semi-permanent makeup in the periocular area);
  • Contraindications to VTP therapy (ocular surgery, ocular injury, ocular herpes of eye or eyelid, and ocular inflammation 3 months before the study; active ocular infection, etc.)
  • Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using a reliable method of contraception.

研究组 & 干预措施

Group A

Experimental

One session VTP at month 0.

干预措施: Vectored thermal pulsation (VTP) therapy (Device)

Group A

Experimental

One session VTP at month 0.

干预措施: Topical eye drops (Hypromellose, 3mg/ml) (Drug)

Group B

Experimental

Four sessions IPL+MGX at month 0,1,2,3.

干预措施: Intense pulsed light with meibomian gland expression (IPL+MGX) therapy (Device)

Group B

Experimental

Four sessions IPL+MGX at month 0,1,2,3.

干预措施: Topical eye drops (Hypromellose, 3mg/ml) (Drug)

Group C

Active Comparator

Twice daily EW for 15 months.

干预措施: Eyelid Warm Compress Therapy (EW) (Behavioral)

Group C

Active Comparator

Twice daily EW for 15 months.

干预措施: Topical eye drops (Hypromellose, 3mg/ml) (Drug)

结局指标

主要结局

Change from baseline Tear film breakup time (TFBUT) at 6 months

时间窗: 6 months

Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.

Change from baseline Tear film breakup time (TFBUT) at 15 months

时间窗: 15 months

Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.

次要结局

  • Change in symptom Assessment iN Dry Eye (SANDE)(15 months)
  • Change in ocular comfort index (OCI)(15 months)
  • Change in tear interferometric fringe pattern(15 months)
  • Change in meiboscore(15 months)
  • Change in Standard Patient Evaluation of Eye Dryness (SPEED)(15 months)
  • Change in lid wiper epitheliopathy (LWE)(15 months)
  • Change in quality of expressed meibum(15 months)
  • Change in non-invasive keratograph break-up time (NIKBUT)(15 months)
  • Change in lower tear meniscus height (TMH)(15 months)
  • Change in lipid layer thickness (LLT)(15 months)
  • Change in partial blinking rate(15 months)
  • Change in Lid margin and eyelash abnormalities(15 months)
  • Change in Ocular Surface Disease Index (OSDI)(15 months)
  • Change in dry eye questionnaire (DEQ-5)(15 months)
  • Change in tear film breakup time (TFBUT)(15 months)
  • Change in bulbar conjunctival hyperaemia(15 months)
  • Change in meibograde(15 months)
  • Change in schirmer's test (ST)(15 months)
  • Change in corneal and conjunctival staining score(15 months)
  • Change in expressibility of meibomian glands in the meibomian glands yielding liquid secretion (MGYLS) (the inferior eyelid)(15 months)
  • Change in expressibility of meibomian glands in proportion of meibomian orifices yielding lipid secretions (the inferior eyelid))(15 months)

研究者

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

Kelvin Kam-lung Chong, MD

Associate Professor, Department of Ophthalmology and Visual Sciences, CUHK

Chinese University of Hong Kong

研究点 (4)

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