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Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) therapies for meibomian gland dysfunction – a multicentre, randomized, assessormasked, active-controlled clinical trial
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注册号：

Registration number：

 ChiCTR2100050323 

最近更新日期：

Date of Last Refreshed on：

 2025-08-28 17:13:06 

注册时间：

Date of Registration：

 2021-08-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) therapies for meibomian gland dysfunction – a multicentre, randomized, assessormasked, active-controlled clinical trial

Public title：

Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) therapies for meibomian gland dysfunction – a multicentre, randomized, assessormasked, active-controlled clinical trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) therapies for meibomian gland dysfunction – a multicentre, randomized, assessormasked, active-controlled clinical trial

Scientific title：

Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) therapies for meibomian gland dysfunction – a multicentre, randomized, assessormasked, active-controlled clinical trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Jennifer Tsoi 

研究负责人：

Dr Chong Kam Lung Kelvin 

Applicant：

Jennifer Tsoi 

Study leader：

Dr Chong Kam Lung Kelvin 

申请注册联系人电话：

Applicant telephone：

 +852 3943 5818

研究负责人电话：

Study leader's
telephone：

+852 3943 5805

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 chongkamlung@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

研究负责人通讯地址：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

Department of Ophthalmology and Visual Sciences, CUHK

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, CUHK

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 KC/KE-21-0127/FR-1

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Research Ethics Committee (Kowloon Central / Kowloon East)

Name of the ethic committee：

Research Ethics Committee (Kowloon Central / Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-25 00:00:00

伦理委员会联系人：

Ms Lyon Chan

Contact Name of the ethic committee：

Ms Lyon Chan

伦理委员会联系地址：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong, China

Contact Address of the ethic committee：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3506 8888

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Food and Health Bureau

Primary sponsor：

Food and Health Bureau

研究实施负责（组长）单位地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong, China

Primary sponsor's address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

具体地址：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Institution
hospital：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

经费或物资来源：

Food and Health Bureau - Health and Medical Research Fund

Source(s) of funding：

Food and Health Bureau - Health and Medical Research Fund

研究疾病：

Meibomian gland dysfunction  

Target disease：

Meibomian gland dysfunction

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

Primary Objective: 1. To compare the efficacy and safety of vectored thermal pulsation (VTP) or intense pulsed light and meibomian gland expression (IPL+MGX) with eyelid warm compress (EW) therapies for meibomian gland dysfunction (MGD). Secondary Objectives: 1. To compare the course of MGD among groups over 15 months (12-month after final IPL+MGX). 2. To identify factors predicting responses to each intervention and compliance to EW.  

Objectives of Study：

Primary Objective: 1. To compare the efficacy and safety of vectored thermal pulsation (VTP) or intense pulsed light and meibomian gland expression (IPL+MGX) with eyelid warm compress (EW) therapies for meibomian gland dysfunction (MGD). Secondary Objectives: 1. To compare the course of MGD among groups over 15 months (12-month after final IPL+MGX). 2. To identify factors predicting responses to each intervention and compliance to EW.

药物成份或治疗方案详述：

Vectored thermal pulsation (VTP) therapy VTP (LipiFlow? Thermal Pulsation System, Johnson & Johnson, USA) purchased from TearScience? with funding from the Health and Medical Research Fund (HMRF) is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Subjects will feel warmth and pressure on their eyelids during the 12-minute bilateral procedure. All subjects are examined at the slit lamp after the procedure. A procedure related pain score by Visual Analogue Scale (VAS) is obtained by the treating investigator immediately. Intense pulsed light with meibomian gland expression (IPL+MGX) therapy IPL is delivered using the proprietary dry eye mode setting of the Lumenis? M22TM system (skin type settings 1–4 and mode A–F) per the Toyos protocol (13). The device is purchased from Lumenis?. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. Adjustment is allowed due to safety (e.g. treatment related pain) and will be recorded. Clear conducting gel will be applied to the inferior, lateral, and medial aspects of the goggles, as per manufacturer recommendations. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times (month 0,1,2,3). Both eyelids are closed and sealed with IPL-Aid disposable eye shields (Honeywell Safety Products, Smithfield, RI). Safety goggles are worn by the unmasked treating investigators and trial coordinator present during IPL. Meibomian gland expression is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. A procedure related pain score by VAS is obtained by the treating investigator immediately. Visual acuity, slit lamp examination to record any iris injury, change in lens opacity by LOCSIII, and external examination on periocular skin, eye lash and eyebrow hair injuries before and after IPL and at each study visit. Each session of IPL and MGX takes about 20 minutes. Both VTP and IPL therapies are not available and have not been adopted in public hospitals under the Hospital Authority. Eyelid Warm Compress Therapy (EW) EW using warm wet towel to each eye is performed twice daily for 10 mins [9-11]. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit. 

Description for medicine or protocol of treatment in detail：

Vectored thermal pulsation (VTP) therapy VTP (LipiFlow? Thermal Pulsation System, Johnson & Johnson, USA) purchased from TearScience? with funding from the Health and Medical Research Fund (HMRF) is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Subjects will feel warmth and pressure on their eyelids during the 12-minute bilateral procedure. All subjects are examined at the slit lamp after the procedure. A procedure related pain score by Visual Analogue Scale (VAS) is obtained by the treating investigator immediately. Intense pulsed light with meibomian gland expression (IPL+MGX) therapy IPL is delivered using the proprietary dry eye mode setting of the Lumenis? M22TM system (skin type settings 1–4 and mode A–F) per the Toyos protocol (13). The device is purchased from Lumenis?. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. Adjustment is allowed due to safety (e.g. treatment related pain) and will be recorded. Clear conducting gel will be applied to the inferior, lateral, and medial aspects of the goggles, as per manufacturer recommendations. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times (month 0,1,2,3). Both eyelids are closed and sealed with IPL-Aid disposable eye shields (Honeywell Safety Products, Smithfield, RI). Safety goggles are worn by the unmasked treating investigators and trial coordinator present during IPL. Meibomian gland expression is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. A procedure related pain score by VAS is obtained by the treating investigator immediately. Visual acuity, slit lamp examination to record any iris injury, change in lens opacity by LOCSIII, and external examination on periocular skin, eye lash and eyebrow hair injuries before and after IPL and at each study visit. Each session of IPL and MGX takes about 20 minutes. Both VTP and IPL therapies are not available and have not been adopted in public hospitals under the Hospital Authority. Eyelid Warm Compress Therapy (EW) EW using warm wet towel to each eye is performed twice daily for 10 mins [9-11]. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit. 

纳入标准：

Inclusion criteria

排除标准：

1.Contact lens wear 3 months before or during the study period; 2.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; 3.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); 4.Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period; 5.History of vision correction surgery or plan to undergo the procedure during the study period; 6.Dermatological treatment (including chemical peeling, laser, IPL or energy device in the periocular and facial region) 6 months before or during the study period; 7.Contraindications to IPL therapy (including recent sun-burn, photosensitivity, active or pigmented skin lesions, cancer, implants, tattoos, semi-permanent makeup in the periocular area); 8.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.); 9.Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using a reliable method of contraception.

Exclusion criteria：

1.Contact lens wear 3 months before or during the study period; 2.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; 3.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); 4.Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period; 5.History of vision correction surgery or plan to undergo the procedure during the study period; 6.Dermatological treatment (including chemical peeling, laser, IPL or energy device in the periocular and facial region) 6 months before or during the study period; 7.Contraindications to IPL therapy (including recent sun-burn, photosensitivity, active or pigmented skin lesions, cancer, implants, tattoos, semi-permanent makeup in the periocular area); 8.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.); 9.Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using a reliable method of contraception.

研究实施时间：

Study execute time：

从 From 2021-10-01 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-10-01 00:00:00 至 To 2024-01-31 00:00:00

干预措施：

Interventions：

组别：

Vectored thermal pulsation

样本量：

 120

Group：

Vectored thermal pulsation

Sample size：

干预措施：

Vectored thermal pulsation

干预措施代码：

Intervention：

Vectored thermal pulsation

Intervention code：

组别：

Intense pulsed light and meibomian gland expression

样本量：

 120

Group：

Intense pulsed light and meibomian gland expression

Sample size：

干预措施：

Intense pulsed light and meibomian gland expression

干预措施代码：

Intervention：

Intense pulsed light and meibomian gland expression

Intervention code：

组别：

Control

样本量：

 120

Group：

Control

Sample size：

干预措施：

Eyelid warm compress therapy

干预措施代码：

Intervention：

Eyelid warm compress therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Hong Kong Eye Hospital 

单位级别：

 三级医院 

Institution
hospital：

Hong Kong Eye Hospital

Level of the institution：

Tertiary

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 CUHK Eye Centre 

单位级别：

 三级医院 

Institution
hospital：

CUHK Eye Centre

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

淚膜破裂時間 (TFBUT)

指标类型：

主要指标

Outcome：

Tear film breakup time (TFBUT)

Type：

Primary indicator

测量时间点：

Month 6, 15

测量方法：

Slit-lamp biomicroscopy

Measure time point of outcome：

Month 6, 15

Measure method：

Slit-lamp biomicroscopy

指标中文名：

MG的連續測量

指标类型：

次要指标

Outcome：

Serial measurements of MG

Type：

Secondary indicator

测量时间点：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

测量方法：

Measure time point of outcome：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

Measure method：

指标中文名：

淚膜相關參數

指标类型：

次要指标

Outcome：

Tear-film related parameters

Type：

Secondary indicator

测量时间点：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

测量方法：

LipiView II

Measure time point of outcome：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

Measure method：

LipiView II

指标中文名：

眼壓

指标类型：

次要指标

Outcome：

Intraocular pressure

Type：

Secondary indicator

测量时间点：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

测量方法：

Tonometry

Measure time point of outcome：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

Measure method：

Tonometry

指标中文名：

符合EW標準

指标类型：

次要指标

Outcome：

Compliance to EW

Type：

Secondary indicator

测量时间点：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

测量方法：

Measure time point of outcome：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

Measure method：

指标中文名：

與 MGD 結果和治療相關併發症相關的因素

指标类型：

次要指标

Outcome：

Factors associated with MGD outcomes and treatment related complications

Type：

Secondary indicator

测量时间点：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

测量方法：

Measure time point of outcome：

Month 0, 1, 2, 3, 4, 6, 9, 12, 15

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

結膜拭子採樣

组织：

Sample Name：

Conjunctival swab sampling

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

瞼板腺脂質樣本取樣

组织：

Sample Name：

Expressed meibum sampling

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液樣本採樣

组织：

Sample Name：

Blood specimens collection

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Randomization will be carried out by a computer-generated minimization program. Minimization is a dynamic process to reduce the imbalance between trial arms with respect to a range of predefined prognostic variables, and a randomisation schedule is therefore not drawn up in advance.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomization will be carried out by a computer-generated minimization program. Minimization is a dynamic process to reduce the imbalance between trial arms with respect to a range of predefined prognostic variables, and a randomisation schedule is therefore not drawn up in advance.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Trial biostatistician will oversee data acquisition, processing and statistical analysis. A unique study number will be assigned to each recruited subject for all study-related documents. The log containing study number to identifiable information will be kept in a locked cabin at the clinical trial office at CUHKEC. All trial-related documents will be maintained by the unmasked trial coordinator to ensure data are accurate, complete, and verifiable from case report forms. Data entry will be cross-checked by a designated technician.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Trial biostatistician will oversee data acquisition, processing and statistical analysis. A unique study number will be assigned to each recruited subject for all study-related documents. The log containing study number to identifiable information will be kept in a locked cabin at the clinical trial office at CUHKEC. All trial-related documents will be maintained by the unmasked trial coordinator to ensure data are accurate, complete, and verifiable from case report forms. Data entry will be cross-checked by a designated technician.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-26 12:47:18
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