ChiCTR2600119285 版本V1.0 版本创建时间2026/02/25 10:39:12 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：

 ChiCTR2600119285 

最近更新日期：

Date of Last Refreshed on：

 2026-02-25 10:38:53 

注册时间：

Date of Registration：

 2026-02-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

正常眼壓青光眼疑似個案及視野缺損早期患者之眼壓藥物調整研究

Public title：

Adjustment of intraocular Pressure (IOP)-lowering medication for Normal Tension Glaucoma (NTG) suspects and pre-perimetric NTG

注册题目简写：

English Acronym：

研究课题的正式科学名称：

正常眼壓青光眼疑似個案及視野缺損早期患者之眼壓藥物調整研究

Scientific title：

Adjustment of intraocular Pressure (IOP)-lowering medication for Normal Tension Glaucoma (NTG) suspects and pre-perimetric NTG

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：

陳培文 

Applicant：

Jennifer Tsoi 

Study leader：

CHAN Pui Man Poemen 

申请注册联系人电话：

Applicant telephone：

 +852 3493 5818

研究负责人电话：

Study leader's
telephone：

+852 3943 5807

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：

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：

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

Study leader's address：

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

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

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

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：

 CIRB-2025-391-3

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：

醫院管理局中央研究倫理委員會

Name of the ethic committee：

Hospital Authority Central Institutional Review Board (Central IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-04 00:00:00

伦理委员会联系人：

Ms Mandy Luk

Contact Name of the ethic committee：

Ms Mandy Luk

伦理委员会联系地址：

九龍亞皆老街147C號衞生防護中心5樓A座A503室

Contact Address of the ethic committee：

A503, 5/F, Block A, Centre for Health Protection, 147C Argyle Street, Kowloon

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2300 8472

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：

香港中文大學醫學院

Primary sponsor：

Faculty of Medicine, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

G/F, Choh-Ming Li Basic Medical Sciences Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Primary sponsor's address：

G/F, Choh-Ming Li Basic Medical Sciences Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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)：

香港中文大學眼科及視覺科學學系

具体地址：

香港九龍亞皆老街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, Hong Kong

经费或物资来源：

香港中文大學研究直接資助計劃

Source(s) of funding：

CUHK Direct Grant for Research

研究疾病：

正常眼壓青光眼疑似個案及視野缺損早期患者  

Target disease：

Normal Tension Glaucoma (NTG) suspects and pre-perimetric NTG

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：

单臂 

Study design：

Single arm 

研究目的：

1. 研究在光學相干層析掃描–趨勢分析（TPA）監測下，暫停使用青光眼藥物一年，對疑似正常眼壓青光眼患者及視野缺損早期的正常眼壓青光眼患者的安全性。 2. 通過調整青光眼藥物，估算對於視野缺損早期的正常眼壓青光眼患者，及疑似正常眼壓青光眼患者可能節省的醫療成本。 3. 通過問卷調查，評估和分析患者在藥物調整前後的生活質素變化。 4. 為正在進行的正常眼壓青光眼隨機對照試驗提供先導數據。  

Objectives of Study：

1. To investigate the safety of withholding intraocular pressure (IOP)-lowering eye drops for normal tension glaucoma (NTG) suspects and pre-perimetric NTG patients for 1 year under monitoring by optical coherence tomography (OCT)- trend-based progressive analysis (TPA) 2. To calculate the potential cost savings that could be achieved with a systematic approach of adjusting medication for PNTG and NTG suspects. 3. To evaluate the quality of life (QOL) changes (assessed by QOL questionnaires) before and after the medication adjustment. 4. To provide pilot data for the ongoing PNTG RCT.

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. 十八歲或以上； 2. BCVA ≥ 20/40； 3. 360° 環形鏡顯示前房角完全開放； 4. 6 個未經治療的眼壓讀數中位數持續 < 21 mmHg，不超過 1 個讀數等於 23 或 24 mmHg，且沒有單次測量值 > 24 mmHg。6個眼壓讀數中，至少有 2 個讀數是在其他不同時段測量所獲得的（用於資格評估的眼壓測量值是在研究前局部使用降低眼壓的藥物 4 週後獲得的）； 5. 三次可靠的VF檢查結果均未顯示符合「青光眼性視野缺損最低標準」的視野缺損； 6. 正常眼壓青光眼疑似個案：眼底照相或 OCT 顯示青光眼變化：神經視網膜邊緣變窄、視盤杯狀 (CDR>0.7)、視盤出血或 RNFL/GCIPL 缺損；RNFL/GCIPL 缺損定義為：(1)在 RNFL/GCIPL 厚度偏差圖中，有 (1)≥ 20 個連續超像素（1 個超像素 = 4x4 像素，儀器預設值）以紅色編碼（即 RNFL/GCIPL 厚度低於第 1 個百分位數）， （2）對應位置的 RNFL/GCIPL 厚度圖也觀察到異常； 7. 視野缺損疑似個案：不具備上述結構性青光眼特徵但被診斷為正常眼壓青光眼的患者； 8. 每位患者的一隻眼睛或兩隻眼睛都可以參與研究。

Inclusion criteria

1. Age >=18 years; 2. BCVA >=20/40; 3. 360° gonioscopically open anterior chamber angles; 4. 6 median untreated IOP reading consistently <21 mmHg, with no more than 1 reading equal to 23 or 24 mmHg and no single measurement >24 mmHg. At least 2 readings were obtained at a different time of the day from the rest (IOP measurement for eligibility assessment are obtained after washout of pre-study topical IOP-lowering medication for 4 weeks); 5. Three reliable VF results without VF defect; 6. PNTG: Fundus photography or OCT show glaucomatous changes: narrowed neuroretinal rim, optic disc cupping, presence of disc hemorrhage, RNFL defect, or GCIPL defect. RNFL defect is defined when (1) >=20 contiguous superpixels (1 superpixel = 4x4 pixels, instrument default) were encoded in red (i.e., RNFL thickness below 1st percentile) in the RNFL thickness deviation map, and (2) the abnormalities were also observed in the RNFL thickness map at the corresponding location); 7. NTG suspect: Patients without the above structural glaucomatous features but was diagnosed NTG. 8. One eye or both eyes of each patient could be recruited for the study.

排除标准：

1. 患者不願意隨機接受治療或觀察； 2. 導致青光眼的次要原因（例如先前的創傷、使用類固醇、葡萄膜炎）； 3. 可能導致 VF 喪失或視盤異常的眼部或全身性疾病； 4. 高度近視（球鏡誤差<-10.0D）； 5. 有青光眼手術、青光眼雷射手術或角膜屈光手術史； 6. 曾接受眼科手術或雷射手術的患者（單純性白內障手術、雷射囊切開術或視網膜屏障雷射手術除外）； 7. 無法獲得可靠的VF檢查結果； 8. OCT影像品質不佳； 9. 符合「青光眼性視野缺損最低標準」的視野缺損：青光眼半視野檢查結果超出正常範圍，模式標準差p<0.05，或單一半視野（上或下）的模式偏差圖中出現三個或以上非邊緣點的群集，其中至少一點達 p<0.01，其餘點達 p<0.05。上述任何一項標準若重複出現，可視為有足夠證據判為青光眼性視野缺損。

Exclusion criteria：

1. Patients unwilling to be monitored without treatment; 2. Second cause of glaucoma (e.g., previous trauma, steroid use, uveitis); 3. Ocular or systemic disease that may cause VF loss or optic disc abnormalities; 4. High myopia (spherical error <-10.0D); 5. history of glaucoma surgery, glaucoma laser procedure, or corneal refractive surgery; 6. Patients who had previous ocular surgery or laser procedure (except uncomplicated cataract surgery, laser capsulotomy, or retinal barrier laser); 7. Inability to perform reliable VF; 8. Suboptimal quality of OCT images; 9. VF defect that fulfills the minimal criterial of glaucomatous VF defect: glaucoma hemifield test result outside normal limits, pattern standard deviation with P<0.05 or a cluster of 3 or more points in the pattern deviation plot in a single hemifield (superior or inferior) with P<0.05 one of which must have P<0.01. Any one of the preceding criteria, if

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2027-03-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2027-03-26 00:00:00

干预措施：

Interventions：

组别：

單一干預組

样本量：

 40

Group：

Single intervention group

Sample size：

干预措施：

調整降眼壓藥物

干预措施代码：

Intervention：

Adjustment of IOP-lowering medication

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

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：

 中國

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

测量指标：

Outcomes：

指标中文名：

透過系統性地調整疑似 PNTG 和 NTG 患者的藥物治療，實現潛在的成本節約。

指标类型：

主要指标

Outcome：

The potential cost-saving that could be achieved with a systematic approach of adjusting medication for PNTG and NTG suspects.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

需要重新開始藥物治療的患者人數統計

指标类型：

次要指标

Outcome：

The number of patients that require resumption of medication.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

無

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 18 岁 years
最大 Max age N/A 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）：

無

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

N/A

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：

無

Blinding：

None

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-02-25 10:38:53