ChiCTR2300067260 版本V1.0 版本创建时间2023/01/01 22:47:02 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300067260 

最近更新日期：

Date of Last Refreshed on：

 2023-01-01 22:46:51 

注册时间：

Date of Registration：

 2023-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

通過成像調整帶有高眼壓的甲狀腺相關眼疾病人的青光眼用藥之隨機對照研究

Public title：

Imaging-guided adjustment of glaucoma medication in patient with Thyroid Associated Orbitopathy with Ocular Hypertension (TAOOH) – a randomized controlled trial (RCT)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

通過成像調整帶有高眼壓的甲狀腺相關眼疾病人的青光眼用藥之隨機對照研究

Scientific title：

Imaging-guided adjustment of glaucoma medication in patient with Thyroid Associated Orbitopathy with Ocular Hypertension (TAOOH) – a randomized controlled trial (RCT)

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：

Ms Jennifer Tsoi 

研究负责人：

陳培文醫生 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Dr CHAN Pui Man Poemen 

申请注册联系人电话：

Applicant telephone：

 +852 39435818

研究负责人电话：

Study leader's
telephone：

+852 39435807

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：

 poemenchan@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：

香港九龍亞皆老街147K號香港眼科醫院3樓

研究负责人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

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：

香港中文大學眼科及視覺科學學系

Applicant's institution：

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

研究负责人所在单位：

香港中文大學眼科及視覺科學學系

Affiliation of the Leader：

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

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：

 2021.744-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-02-09 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

香港新界沙田銀城街30-32號威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

香港中文大學眼科及視覺科學學系；醫務衞生局研究處

Primary sponsor：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong；Research Office, Health Bureau

研究实施负责（组长）单位地址：

香港九龍亞皆老街147K號香港眼科醫院3樓；香港上環林士街2號林士街多層停車場9樓

Primary sponsor's address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong；9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學眼科及視覺科學學系

具体地址：

九龍亞皆老街147K號香港眼科醫院3樓

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：

醫療衞生研究基金

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

帶有高眼壓的甲狀腺相關眼疾  

Target disease：

Thyroid Associated Orbitopathy with Ocular Hypertension

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：

随机平行对照 

Study design：

Parallel 

研究目的：

兩組2年內的治療成果將透過需使用青光眼眼藥水的患者比例和視野進展情況、總治療費用，以及乾眼症（DED）相關參數進行比較。我們希望研究在TPA引導下調整TAOOH患者青光眼用藥要求的安全性和影響。  

Objectives of Study：

The treatment outcomes of the two groups will be compared in terms of the proportion of patients requiring glaucoma eye drops and visual field (VF) progression, the total treatment cost, and the dry eye disease (DED)-related parameters in 2 years. We hope to investigate the safety and impact of adjusting glaucoma medication requirement in TAOOH patients guided by TPA.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Open angle on gonioscopy,
2. Visual acuity of at least 20/40 on Snellen Chart,
3. Diagnosed of thyroid associated orbitopathy (TAO), according to the Bartley and Gorman criteria21, with inactive, non-progressive disease,
4. Intraocular pressure (IOP) between 21 to 32mmHg (at primary position) without any glaucoma eye drops (OR patients on glaucoma medication who has a documented history of IOP elevation of > 21mmHg at the primary position),
5. Patients that underwent MRI orbital imaging during the quiescent phase.
6. Able to perform reliable Humphrey visual field (VF) test.
7. Able to take good quality ocular coherence tomography (OCT) images for retinal nerve fiber layers (RNFL), ganglion cell-inner plexiform layer (GCIPL), and RNFL optical texture analysis (ROTA), and
8. No functional and structural evidence of glaucomatous optic neuropathy (GON) – 2 reliable VF without VF defect, normal optic disc configuration without neuroretinal rim and/or RNFL in clinical examination, and normal OCT RNFL measurements without RNFL abnormalities (i.e., within the 95% normal ranges) in the RNFL thickness deviation map.

Inclusion criteria

1. Open angle on gonioscopy,
2. Visual acuity of at least 20/40 on Snellen Chart,
3. Diagnosed of thyroid associated orbitopathy (TAO), according to the Bartley and Gorman criteria21, with inactive, non-progressive disease,
4. Intraocular pressure (IOP) between 21 to 32mmHg (at primary position) without any glaucoma eye drops (OR patients on glaucoma medication who has a documented history of IOP elevation of > 21mmHg at the primary position),
5. Patients that underwent MRI orbital imaging during the quiescent phase.
6. Able to perform reliable Humphrey visual field (VF) test.
7. Able to take good quality ocular coherence tomography (OCT) images for retinal nerve fiber layers (RNFL), ganglion cell-inner plexiform layer (GCIPL), and RNFL optical texture analysis (ROTA), and
8. No functional and structural evidence of glaucomatous optic neuropathy (GON) – 2 reliable VF without VF defect, normal optic disc configuration without neuroretinal rim and/or RNFL in clinical examination, and normal OCT RNFL measurements without RNFL abnormalities (i.e., within the 95% normal ranges) in the RNFL thickness deviation map.

排除标准：

1. Eye with glaucomatous VF defect:19
- Glaucoma hemifield test (GHT) outside normal limit,
- Pattern standard deviation (PSD) with p-value <5%,
- A cluster of ≥3 non-edged points in the pattern deviation plot in a single hemifield with p-value <5%, one of which must have a p-value <1%.
Any one of these criteria, if repeatable for 3 times, was considered as sufficient evidence of a glaucomatous VF defect,
2. VF with fixation losses, false positive and false negative errors ≥20%,
3. Unable to take OCT images with good quality [See the session on Optical coherence tomography (OCT)],
4. Patient with evidence of angle closure or extensive peripheral anterior synechiae (more than 180o),
5. TAO in the active phase (clinical activity score ≥3),
6. Patients with unstable thyroid function test,
7. Patients with evidence of dysthyroid optic neuropathy – clinical evidence or optic nerve compression on contrast magnetic resonance imaging (MRI) of the orbit.
8. Known history of glaucoma prior to the occurrence of TAO,
9. Other secondary causes of IOP elevation (e.g. uveitis, trauma, neovascular glaucoma, subluxed lens),
10. History of ocular or intraocular surgery except for orbital decompression, orbital irradiation, or uneventful cataract surgery >6 months prior to the recruitment,
11. Previous laser procedures (except YAG capsulotomy and retinal barrier laser >6 months prior to the recruitment),
12. Use of steroid in <6 months, and
13. One eye patient.

Exclusion criteria：

1. Eye with glaucomatous VF defect:19
- Glaucoma hemifield test (GHT) outside normal limit,
- Pattern standard deviation (PSD) with p-value <5%,
- A cluster of ≥3 non-edged points in the pattern deviation plot in a single hemifield with p-value <5%, one of which must have a p-value <1%.
Any one of these criteria, if repeatable for 3 times, was considered as sufficient evidence of a glaucomatous VF defect,
2. VF with fixation losses, false positive and false negative errors ≥20%,
3. Unable to take OCT images with good quality [See the session on Optical coherence tomography (OCT)],
4. Patient with evidence of angle closure or extensive peripheral anterior synechiae (more than 180o),
5. TAO in the active phase (clinical activity score ≥3),
6. Patients with unstable thyroid function test,
7. Patients with evidence of dysthyroid optic neuropathy – clinical evidence or optic nerve compression on contrast magnetic resonance imaging (MRI) of the orbit.
8. Known history of glaucoma prior to the occurrence of TAO,
9. Other secondary causes of IOP elevation (e.g. uveitis, trauma, neovascular glaucoma, subluxed lens),
10. History of ocular or intraocular surgery except for orbital decompression, orbital irradiation, or uneventful cataract surgery >6 months prior to the recruitment,
11. Previous laser procedures (except YAG capsulotomy and retinal barrier laser >6 months prior to the recruitment),
12. Use of steroid in <6 months, and
13. One eye patient.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：

以光學相干斷層掃描趨勢為本的進展分析组

样本量：

 80

Group：

Optical coherence tomography (OCT) trend-based progression analysis (TPA)-guided group

Sample size：

干预措施：

臨床檢查、甲狀腺相關眼疾檢查、視野檢查、光學相干斷層掃描、乾眼評估；視網膜神經纖維層（RNFL）出現漸進性變薄時開始降眼壓治療

干预措施代码：

Intervention：

Clinical examination, TAO examination, perimetry, OCT imaging, dry eye assessments; IOP-lowering treatment initiated to eyes with progressive retinal nerve fiber layer (RNFL) thinning

Intervention code：

组别：

以眼壓引導组

样本量：

 80

Group：

IOP-guided group

Sample size：

干预措施：

臨床檢查、甲狀腺相關眼疾檢查、視野檢查、光學相干斷層掃描、乾眼評估；連續兩次覆診眼壓超過21mmHg時開始降眼壓治療

干预措施代码：

Intervention：

Clinical examination, TAO examination, perimetry, OCT imaging, dry eye assessments; IOP-lowering treatment initiated to eyes with IOP higher than 21mmHg in two consecutive visits

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港眼科醫院 

单位级别：

 N/A 

Institution
hospital：

Hong Kong Eye Hospital

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 威爾斯親王醫院 

单位级别：

 N/A 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 雅麗氏何妙齡那打素醫院 

单位级别：

 N/A 

Institution
hospital：

Alice Ho Miu Ling Nethersole Hospital

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港中文大學眼科中心 

单位级别：

 N/A 

Institution
hospital：

CUHK Eye Centre

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 葛量洪醫院 

单位级别：

 N/A 

Institution
hospital：

Grantham Hospital

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 東華東院 

单位级别：

 N/A 

Institution
hospital：

Tung Wah Eastern Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

2年內需要降眼壓治療的患者比例

指标类型：

主要指标

Outcome：

The proportion of patients requiring IOP-lowering treatment in 2 years

Type：

Primary indicator

测量时间点：

每4個月

测量方法：

Measure time point of outcome：

Every 4 months

Measure method：

指标中文名：

視野進展患者的比例

指标类型：

次要指标

Outcome：

The proportion of patients with VF progression

Type：

Secondary indicator

测量时间点：

每4個月

测量方法：

Measure time point of outcome：

Every 4 months

Measure method：

指标中文名：

總治療成本

指标类型：

次要指标

Outcome：

Total treatment cost

Type：

Secondary indicator

测量时间点：

第24個月

测量方法：

Measure time point of outcome：

Month 24

Measure method：

指标中文名：

2年內乾眼相關參數

指标类型：

次要指标

Outcome：

The dry eye-related parameters in 2 years

Type：

Secondary indicator

测量时间点：

基線訪問、第12個月

测量方法：

乾眼評估

Measure time point of outcome：

Baseline visit, month 12

Measure method：

Dry eye assessments

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

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

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

一名指定的研究助理會以隨機數字表配合年齡、性別、吸煙歷史、TAO治療歷史的相關因素分配參與者至A或B組。參與者和研究醫生都不會知道分組結果。

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

Participants will be randomized by a designated research assistant into Group A or B using a random number table with age, sex, smoking history, and history of TAO treatment accounted for. Both the participants and investigators will not know the grouping results.

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）：

N/A

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

N/A

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：

Patient data will be handled with utmost care so as not to breach patient privacy in any form. The data will be stored in secure cabinets and/or computers which will be password operated. To protect patient privacy, all research data will be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data will be saved in secured computers with restricted access. USB Device will not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) will not be recorded on the project’s data sheets or electronic files. A non-recognizable study code will be used for each patient instead. The document of electronic file containing the linkage information between the study code and the identity of the patient will not contain any other information and will be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information will be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. All of the investigators will be responsible for data handling and protection.

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

Patient data will be handled with utmost care so as not to breach patient privacy in any form. The data will be stored in secure cabinets and/or computers which will be password operated. To protect patient privacy, all research data will be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data will be saved in secured computers with restricted access. USB Device will not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) will not be recorded on the project’s data sheets or electronic files. A non-recognizable study code will be used for each patient instead. The document of electronic file containing the linkage information between the study code and the identity of the patient will not contain any other information and will be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information will be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. All of the investigators will be responsible for data handling and protection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-01-01 22:46:52