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内镜经筛眶减压联合I期斜视矫正手术治疗TAO伴水平斜视：一项多中心、随机、对照研究
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注册号：

Registration number：

 ChiCTR2600125972 

最近更新日期：

Date of Last Refreshed on：

 2026-06-01 22:05:43 

注册时间：

Date of Registration：

 2026-06-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

内镜经筛眶减压联合I期斜视矫正手术治疗TAO伴水平斜视：一项多中心、随机、对照研究

Public title：

Endoscopic Transethmoidal Orbital Decompression Combined with One-Stage Strabismus Correction Surgery for TAO with Horizontal Strabismus: A Multicenter, Randomized, Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

内镜经筛眶减压联合I期斜视矫正手术治疗TAO伴水平斜视：一项多中心、随机、对照研究

Scientific title：

Endoscopic Transethmoidal Orbital Decompression Combined with One-Stage Strabismus Correction Surgery for TAO with Horizontal Strabismus: A Multicenter, Randomized, Controlled 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：

涂云海 

研究负责人：

涂云海 

Applicant：

Yunhai TU 

Study leader：

Yunhai Tu 

申请注册联系人电话：

Applicant telephone：

 +86 577 8806 8861

研究负责人电话：

Study leader's
telephone：

+86 577 8806 8861

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：

 tyh5@21cn.com

研究负责人电子邮件：

Study leader's E-mail：

 tyh5@21cn.com

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：

浙江省温州市鹿城区学院西路270号

研究负责人通讯地址：

浙江省温州市鹿城区学院西路270号

Applicant address：

270 West Xueyuan Road, Wenzhou, Zhejiang,China

Study leader's address：

270 West Xueyuan Road, Wenzhou, Zhejiang,China

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：

温州医科大学附属眼视光医院

Applicant's institution：

Eye Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属眼视光医院

Affiliation of the Leader：

Eye Hospital, Wenzhou Medical University

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：

 温医大眼视光伦审2026研第089号

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：

温州医科大学附属眼视光医院伦理委员会

Name of the ethic committee：

Ethics committee of Eye Hospital of Wenzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-20 00:00:00

伦理委员会联系人：

谷佩秋

Contact Name of the ethic committee：

Gu PeiQiu

伦理委员会联系地址：

浙江省温州市鹿城区学院西路270号

Contact Address of the ethic committee：

270 West Xueyuan Road, Wenzhou, Zhejiang,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 577 8807 5582

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gupeiqiu@126.com

研究实施负责（组长）单位：

温州医科大学附属眼视光医院

Primary sponsor：

Eye Hospital, Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市鹿城区学院西路270号

Primary sponsor's address：

270 West Xueyuan Road, Wenzhou, Zhejiang,China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属眼视光医院

具体地址：

浙江省温州市鹿城区学院西路270号

Institution
hospital：

Eye Hospital, Wenzhou Medical University

Address：

270 West Xueyuan Road, Wenzhou, Zhejiang,China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised

研究疾病：

甲状腺相关性眼病；限制性斜视  

Target disease：

Thyroid-associated ophthalmopathy；restrictive strabismus

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：

比较一期眶壁减压手术联合斜视矫正手术与传统的分阶段手术治疗甲状腺相关性眼病患者水平斜视的有效性和安全性。  

Objectives of Study：

Comparing of the efficacy and safety of one-stage orbital wall decompression surgery combined with strabismus correction surgery versus traditional staged surgery for the treatment of horizontal strabismus in patients with thyroid-associated ophthalmopathy.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.斜视是由于其他病因所致；
2.存在眼部先天性疾病或发育异常影响眼外肌功能，如先天性眼外肌纤维化等；
3.既往接受过眼睑或眼眶减压手术；
4.有眼部外伤史且未完全恢复；
5.甲状腺功能不稳定、近半年内接受过激素冲击治疗、I131治疗、眼眶放射治疗；
6.需要紧急接受眶手术的威胁视力的TAO患者（如视神经受累、角膜溃疡）；
7.合并其他影响视力的眼病，如青光眼、严重屈光介质浑浊、视网膜脱离、黄斑病变和视神经病变等；
8.存在眼部感染性疾病，如结膜炎、角膜炎、眼内炎等；
9.未控制的高血压（收缩压＞180mmHg 和/或 舒张压＞110mmHg）、不稳定型心绞痛、近期发生过心肌梗死等；
10.未控制的糖尿病（如空腹血糖＞6 mmol/L和/或 糖化血红蛋白＞9%）；严重的肝肾功能不全，肝肾功能异常；
11.有自身免疫性疾病活动期（除 TAO 外），如系统性红斑狼疮、类风湿关节炎等；
12.有凝血功能障碍或正在服用影响凝血功能的药物（如华法林、阿司匹林等，且不能停药）；
13.有恶性肿瘤病史且正在接受放化疗；
14.其他身体情况不允许接受手术治疗的患者，如妊娠期/哺乳期妇女、精神病病史、药物成瘾史等；

Exclusion criteria：

1.The strabismus is caused by any other factor;
2.The presence of congenital eye diseases or developmental abnormalities that affect extraocular muscle function, such as congenital fibrosis of the extraocular muscles;
3.Previous eyelid or orbital surgery;
4.History of ocular trauma with incomplete recovery;
5.Unstable thyroid function, receipt of pulse steroid therapy, I-131 therapy, or orbital radiotherapy within the past six months;
6.TAO patients with sight-threatening conditions requiring urgent orbital surgery (optic nerve involvement，corneal ulcer);
7.Concomitant with other vision-affecting eye diseases, such as glaucoma, severe media opacities, retinal detachment, maculopathy, and optic neuropathy;
8.Presence of ocular infectious diseases, such as conjunctivitis, keratitis, endophthalmitis;
9.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg), unstable angina, recent myocardial infarction;
10.Uncontrolled diabetes mellitus (fasting blood glucose >6 mmol/L and/or glycated hemoglobin >9%); severe hepatic and renal insufficiency, abnormal liver and kidney function.
11.Active autoimmune diseases (other than TAO), such as systemic lupus erythematosus, rheumatoid arthritis;
12.Presence of coagulation disorders or current use of medications that affect coagulation function (such as warfarin, aspirin) that cannot be discontinued.
13.History of malignant tumor and currently undergoing radiotherapy or chemotherapy;
14.Other physical conditions that preclude surgical treatment, such as pregnant/lactating women, history of psychiatric disorders, history of drug addiction;

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2027-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-03-31 00:00:00

干预措施：

Interventions：

组别：

联合手术组

样本量：

 135

Group：

combined group

Sample size：

干预措施：

接受眶减压术的同时接受斜视矫正手术

干预措施代码：

Intervention：

Orbital decompression with strabismus correction surgery

Intervention code：

组别：

分期手术组

样本量：

 135

Group：

staged group

Sample size：

干预措施：

先接受眶减压术，术后3-6个月再次接受斜视矫正手术

干预措施代码：

Intervention：

First undergo orbital decompression surgery, followed by strabismus correction surgery again 3–6 months postoperatively.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 温州医科大学附属眼视光医院 

单位级别：

 三级甲等 

Institution
hospital：

Eye Hospital, Wenzhou Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 辽宁省 

市(区县)：

  

Country：

China

Province：

Liaoning

City：

单位(医院)：

 沈阳市第四人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Shenyang The Fourth Hospital of People

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国人民解放军总医院第三医学中心 

单位级别：

 三级甲等 

Institution
hospital：

The Third Medical Center of Chinese People’s Liberation Army General Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 甘肃省 

市(区县)：

  

Country：

China

Province：

Gansu

City：

单位(医院)：

 兰州市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Lanzhou First People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

  

Country：

China

Province：

Fujian

City：

单位(医院)：

 福州爱尔眼科医院 

单位级别：

 三级医院 

Institution
hospital：

Fuzhou Aier EYE Hospital

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 黑龙江省 

市(区县)：

  

Country：

China

Province：

Heilongjiang

City：

单位(医院)：

 哈尔滨医科大学附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Harbin Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 新疆维吾尔自治区 

市(区县)：

  

Country：

China

Province：

Xinjiang Uygur Autonomous Region

City：

单位(医院)：

 新疆维吾尔自治区中医医院 

单位级别：

 三级甲等 

Institution
hospital：

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 宁夏回族自治区 

市(区县)：

  

Country：

China

Province：

Ningxia Hui Autonomous Region

City：

单位(医院)：

 宁夏眼科医院 

单位级别：

 三级甲等 

Institution
hospital：

Ningxia Eye Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 温州医科大学附属眼视光医院杭州院区 

单位级别：

 三级甲等 

Institution
hospital：

Eye Hospital of Wenzhou Medical University at Hangzhou

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 天津市 

市(区县)：

  

Country：

China

Province：

Tianjin

City：

单位(医院)：

 天津市眼科医院 

单位级别：

 三级甲等 

Institution
hospital：

Tianjin Eye Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

  

Country：

China

Province：

Henan

City：

单位(医院)：

 河南省立眼科医院 

单位级别：

 三级甲等 

Institution
hospital：

Henan Eye Hospital, Henan Eye Institute

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆医科大学附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Chongqing Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东省立医院（山东省儿童医院） 

单位级别：

 三级甲等 

Institution
hospital：

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 核工业四一六医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Chengdu Medical College, Nuclear Industry 416 Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

眼球运动评分

指标类型：

主要指标

Outcome：

Eye movement

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

受试者手术前与术后每次随访都应行眼位照相检查，并参照麦光焕介绍的眼外肌亢进与不足程度的分级方法进行眼球运动情况评价。检查者手持点光源于受试者眼前 40cm 处，引导受试者跟随注视点光源向6 个诊断眼位转动眼球，观察受试者双眼转动情况并记录。0到-4分制（0 代表完全运动，-4 代表无法通过中线），对每只眼睛的外展、内收、上转和下转进行评分。4个方向负值总和最大的眼睛被认为是受影响较大的眼睛。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Ocular alignment photography was performed preoperatively and at each follow-up. Ocular motility was assessed using the method of Mai Guanghuan, with a point light source at 40 cm guiding the six cardinal gazes. Each eye was scored from 0 to -4 for abduction, adduction, elevation, and depression (0=full movement, -4=unable to cross midline). The eye with the largest negative sum was considered the more affected eye.

指标中文名：

临床活动性评分

指标类型：

次要指标

Outcome：

CAS score

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

根据EUGOGO指南对受试者进行活动性评分，具体项目如下，每项一分：a）自发性眼眶疼痛；b）眼球运动诱发疼痛；c）眼睑水肿；d）眼睑充血；e）结膜充血；f）球结膜水肿；g）泪阜或皱襞肿胀。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The clinical activity score was evaluated according to the EUGOGO guidelines. The following items were assessed, each scoring one point: a) Spontaneous orbital pain; b) Pain on eye movement; c) Eyelid edema; d) Eyelid erythema; e) Conjunctival redness; f) Chemosis; g) Swelling of the caruncle or plica.

指标中文名：

OCT 及OCTA 检查

指标类型：

次要指标

Outcome：

OCT and OCTA examination

Type：

Secondary indicator

测量时间点：

术前、术后3月、术后6月

测量方法：

检查采用美国 Optovue 公司生产的光学相干断层扫描仪对所有受试者行眼底黄斑区及视盘区检查，经该仪器采集的眼底视盘图像存于计算机，经其自带的 OCTA 软件进行分析，分别计算鼻侧、颞侧、上方、下方、 中央以及平均视神经纤维厚度以及视网膜血管密度各项参数。

Measure time point of outcome：

Preoperative, 3 months, 6 months postoperative

Measure method：

The examination was performed on all subjects using an optical coherence tomography scanner (manufactured by Optovue, Inc., USA) to image the macular and optic disc regions of the fundus. The optic disc images acquired by the instrument were stored in a computer and analyzed using its built?in OCTA software. Various parameters were calculated, including the retinal nerve fiber layer thickness in the nasal, temporal, superior, inferior, and central regions, as well as the overall average thicknes

指标中文名：

体格检查

指标类型：

次要指标

Outcome：

Physical examination

Type：

Secondary indicator

测量时间点：

术前，术后6月

测量方法：

全面体格检查至少包括对肌肉骨骼状况、胃肠道、肺脏、心血管、呼吸系统和神经系统以及一般外观、皮肤和淋巴结的评估。还将脱鞋和穿着轻便衣物测量身高和体重，并使用经验证的工具进行记录。将在术前和术后6月时进行全面体格检查。简化体格检查将包括胃肠道、肺、心血管和呼吸系统以及一般外观评估。将在其他随访时间点进行简化体格检查。

Measure time point of outcome：

Preoperative, 6 months postoperative

Measure method：

Comprehensive physical examination included assessments of the musculoskeletal, gastrointestinal, pulmonary, cardiovascular, respiratory, and nervous systems, as well as general appearance, skin, and lymph nodes. Height and weight were measured (without shoes, light clothing) using validated instruments. The comprehensive exam was performed preoperatively and at 6 months postoperatively. A simplified exam (gastrointestinal, pulmonary, cardiovascular, respiratory systems, and general appearance)

指标中文名：

眼眶高分辨率CT成像

指标类型：

主要指标

Outcome：

HRCT

Type：

Primary indicator

测量时间点：

术前、术后6月

测量方法：

采用 SOMATTOM Emotion 16 Slice Configuration 进行眼眶冠状面及水平面扫描，窗宽 300-500HU，窗平 35-50HU，层面厚度 0.75mm，扫描时受试者始终保持第一眼位。根据 Barrett 等人的方法测量眼肌指数（MI），根据Gorman 等人的方法测量直肌最大直径。

Measure time point of outcome：

Preoperative, 6 months postoperative

Measure method：

Orbital CT scans were performed using a SOMATOM Emotion 16 Slice Configuration in the coronal and axial planes, with a window width of 300–500 HU, window level of 35–50 HU, and slice thickness of 0.75 mm. Subjects maintained primary gaze throughout the scan. The extraocular muscle index (MI) was measured according to the method described by Barrett et al., and the maximum diameter of the rectus muscle was measured according to the method described by Gorman et al.

指标中文名：

视野

指标类型：

主要指标

Outcome：

Vision field

Type：

Primary indicator

测量时间点：

术前、术后3月、术后6月

测量方法：

采用Humphrey视野计, 检查策略采用program 24-2 SITA standard。假阴性率与假阳性率均低于15%以及固视丢失率小于20%的检查结果视为可信。所有检查由一位技师检查完成，使用试镜片进行屈光矫正和按设备说明提供老视附加镜片，散光用等效球镜矫正；给被检查者标准的检查前指导；调整好受试者坐位，首次接受检查者先运行1分钟的演示模式；测试过程中对各项影响结果的事项进行监督；检查过

Measure time point of outcome：

Preoperative, 3 months, 6 months postoperative

Measure method：

The Humphrey visual field analyzer (program 24-2 SITA standard) was used. Results were considered reliable when false negatives, false positives <15% and fixation loss <20%. All tests were performed by one technician. Refractive errors were corrected using trial lenses with near add as per device instructions; astigmatism corrected with spherical equivalent. Standard pretest instructions were given, the subject’s position adjusted, and a 1-minute demonstration mode was run for first-time examine

指标中文名：

心电图

指标类型：

次要指标

Outcome：

ECG

Type：

Secondary indicator

测量时间点：

术前

测量方法：

使用 ECG 仪进行单次 12 导联（或更高，按照当地标准实践）ECG 检查。

Measure time point of outcome：

Preoperative

Measure method：

Electrocardiogram (ECG) was performed preoperatively. A single 12-lead (or higher, according to local standard practice) ECG was recorded using an ECG machine.

指标中文名：

格雷夫斯眼眶病生活质量量表总评分

指标类型：

次要指标

Outcome：

GO-QoL

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

GO-QoL 量表包括 2 个自评子量表：一个测量视觉功能对日常活动的影响，另一个测量对社会功能（自我感知外貌）的影响。每个子量表包括 8 个问题，回答如下：是-非常多；是-有一点；或否-完全没有。每个问题的评分范围为 0 至 2，将原始总评分转换为 0 至 100 分量表，其中 0 代表对QoL 的负面影响最大，100 代表无影响。基于效应量，GO-QoL 评分变化约 20 分可解释为较大效应，

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The GO-QoL includes two self-reported subscales: one on visual function impact and one on psychosocial functioning (self-perceived appearance). Raw scores (0–2 per question) are converted to a 0–100 scale (0 = worst QoL, 100 = best). A change of ~20 points indicates a large effect, ~10 points a small-to-moderate effect, and 3–4 points a minimal effect. The minimal clinically important difference is 6–10 points. A composite score can also be calculated. The GO-QoL is the preferred tool for assess

指标中文名：

视力

指标类型：

主要指标

Outcome：

Vision acuity

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

使用标准对数视力表，测量受试者的裸眼视力、生活视力和最佳矫正视力（best-corrected visual acuity，BVCA），结果以小数方式记录检查结果，最终统一转换为最小分辨角对数值（logarithm of theminimum angle of resolution，logMAR）数值记录。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Using a standard logarithmic visual acuity chart, the uncorrected visual acuity, habitual visual acuity, and best-corrected visual acuity (BCVA) of the subjects were recorded in decimal notation, and the results were ultimately converted to logarithm of the minimum angle of resolution (logMAR) values.

指标中文名：

严重程度评估

指标类型：

次要指标

Outcome：

Severity assessment

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

TAO 的严重程度将根据 EUGOGO分级和生活质量评分进行评估。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The severity of TAO will be assessed according to the EUGOGO classification and quality of life score.

指标中文名：

同视机

指标类型：

主要指标

Outcome：

Synoptophore

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

采用六六 YZ23B 同视机对受试者分别进行客观及主观斜视角的测量。检查者需要在 9 个方位分别测量受试者的斜视角度。受试者需取坐位，调整座椅与颏架的高度，调整两个镜筒的瞳距，使受试者双眼与两个镜筒对齐。若受试者有屈光不正，则需要佩戴眼镜矫正至最佳视力再接受检查。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

A six-six YZ23B synoptophore was used to measure the objective and subjective angles of deviation in the subjects. The examiner measured the strabismus angle in nine gaze positions. The subject was seated, with the seat and chin rest adjusted to the appropriate height, and the interpupillary distance of the two tubes was adjusted to align the subject’s eyes with the tubes. If the subject had refractive errors, they were required to wear their corrective lenses to achieve best-corrected vision be

指标中文名：

裂隙灯及前置镜

指标类型：

主要指标

Outcome：

Slit lamp and fundus lens

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

使用裂隙灯弥散光照射法及直接焦点照明法检查受试者眼前节，前置镜下行眼底检查，并记录眼表和眼底的情况。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The anterior segment of the subjects was examined using the slit lamp with diffuse illumination and direct focal illumination methods, and fundus examination was performed with a fundus lens. The findings of the ocular surface and fundus were recorded.

指标中文名：

眼位检查

指标类型：

次要指标

Outcome：

Ocular alignment examination

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

受试者术前与术后每次复查均采用 Hirschberg 角膜映光法在门诊检查眼位偏斜情况。检查者通过观察受试者角膜光反射的位置及其与瞳孔的关系来判断受试者眼位情和斜视度。将点光源置于受试者眼前 33cm 处，嘱受试者注视，观察受试者双眼角膜上点光源的反射位置。若反光点位于瞳孔缘处，则斜视角度为 10°至 15°；若位于角膜缘与瞳孔缘中央，则斜视角度为 25°至 30°；若位于角膜缘处，则斜视角度为

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The Hirschberg corneal light reflex test was performed preoperatively and at each follow-up. A point light source was placed 33 cm in front of the eyes. The angle of deviation was estimated based on the reflex position relative to the pupil: at pupillary margin = 10°–15°, midway = 25°–30°, at limbus = 45°. Circumferential degrees can be converted to prism diopters (1 cm/m = 1 PD); 1° ≈ 1.75 PD.

指标中文名：

血液标本检测

指标类型：

次要指标

Outcome：

Blood

Type：

Secondary indicator

测量时间点：

术前，术后6月

测量方法：

采取每位受试者入组和出组时的空腹静脉血液样本5ml于含EDTA抗凝剂的采血管中，4℃恒温箱内保存，2h内完成离心（4℃ 3000rpm离心10min）。离心后分装上层血浆于冻存管中，存放于-80℃冰箱，直至所有受试者招募完毕，一同检测。将在中心实验室分析血液样本，以确定甲状腺功能等。

Measure time point of outcome：

Preoperative, 6 months postoperative

Measure method：

Fasting venous blood samples (5 ml) were collected from each subject at enrollment and exit using EDTA-anticoagulant tubes. The samples were stored in a 4°C constant-temperature refrigerator and centrifuged within 2 hours (centrifugation at 4°C, 3000 rpm for 10 minutes). After centrifugation, the supernatant plasma was aliquoted into cryotubes and stored at -80°C until all subjects had been recruited, after which the samples were tested together. Blood samples were analyzed at a central laborato

指标中文名：

立体视

指标类型：

主要指标

Outcome：

Stereopsis

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

应用 Titmus 立体图（Titmus stereotest）、TNO 立体图(TNO stereotest)来检查受试者的近立体视功能。应用 Randot 远立体视觉检查图来检查受试者的远立体视功能。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Near stereopsis was assessed using the Titmus stereotest and TNO stereotest. Distance stereopsis was assessed using the Randot stereotest.

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

Vital signs

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

在采血前，需记录体温、脉搏率、呼吸频率和血压。在受试者静坐休息状态下，使用水银血压计测量血压和脉搏率，测量位置始终固定在右臂上。测量结果共进行两次并取平均值。脉压（PP）的计算方法为收缩压（SBP）减去舒张压（DBP）。所有测量均由同一位检查者完成。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Vital signs were measured preoperatively and at each follow-up. Body temperature, pulse rate, respiratory rate, and blood pressure were recorded before blood sampling. Blood pressure and pulse rate were assessed with the subject seated at rest, using a mercury sphygmomanometer, always on the right arm. Measurements were taken twice and averaged. Pulse pressure (PP) was calculated as systolic blood pressure (SBP) minus diastolic blood pressure (DBP). All measurements were performed by the same ex

指标中文名：

眼压

指标类型：

主要指标

Outcome：

Intraocular pressure

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

使用非接触式眼压计 Topcon Full Auto Tonometer TX-20对受试者测量眼压，测量三次取平均值记录。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Intraocular pressure (IOP) was measured using a non-contact tonometer, Topcon Full Auto Tonometer TX-20. Measurements were taken three times, and the average value was recorded.

指标中文名：

双眼视功能检查

指标类型：

次要指标

Outcome：

Binocular Visual Function Test

Type：

Secondary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

Worth 四点灯试验：在相同亮度的环境中用手电筒式 Worth 四点灯检查受试者的融合功能，受试者戴红绿眼镜，右眼为红片，左眼为绿片，分别在近处（33cm）和远处（5m）行 Worth 四点灯检查。若受试者看到 4 个灯说明没有单眼抑制且无斜视。若受检者看到 5 个灯表明受检者有斜视，无单眼抑制。左眼抑制的表现为只看到 2 个红灯，右眼抑制的表现为只看到 3 个绿灯。此外 Worth 四点灯还可

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The Worth four-dot test assessed fusion. In a uniformly lit environment, subjects wore red-green glasses (right eye red, left eye green) and were tested at near (33 cm) and distance (5 m). Four dots indicated no suppression or strabismus; five dots indicated strabismus without suppression. Two red dots indicated left eye suppression; three green dots indicated right eye suppression. Ocular dominance: four dots (two red, two green) = right eye dominance; three green, one red = left eye dominance.

指标中文名：

眼球突出度

指标类型：

主要指标

Outcome：

Exophthalmos

Type：

Primary indicator

测量时间点：

术前、术后1周、术后1月、术后3月、术后6月

测量方法：

使用 K-0161 Hertel 眼突计由同一位检查者对受试者进行眼球突出度测量，具体方法为：检查者与受试者同高度面对面坐，检查者将突眼计的两端支撑在受试者两侧眶外壁的前缘，嘱受试者向前平视，记录两平面镜中角膜定点对应的刻度值即为眼球突出度；平杆上的刻度即为眶距。

Measure time point of outcome：

Preoperative, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

The exophthalmos measurement was performed by the same examiner using a K-0161 Hertel exophthalmometer. The specific method was as follows: the examiner sat face-to-face with the subject at the same height, placed the two ends of the exophthalmometer against the anterior margins of the lateral orbital rims on both sides of the subject, and instructed the subject to look straight ahead. The scale value corresponding to the corneal apex in the two mirrors was recorded as the degree of exophthalmos

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液样本

组织：

Sample Name：

Blood

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

随机序列由独立统计师使用SAS软件生成，采用区组长度为4或6的可变区组设计，确保每家中心内两组样本量均衡。

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

Random sequences were generated by an independent statitidan using SAS soltware ith a variable block design featuring block lengths of4 or to ensure balanced sample sizesbetween the two groups within each center.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

本研究的原始数据将在研究结果发表后，为符合学术规范的外部研究者提供合理共享。外部人员需向研究团队提交书面数据使用申请(含研究目的、使用范围、数据保密承诺)，经审核通过后，将提供脱敏后的原始数据(去除受试者隐私信息，保留可溯源的匿名化检测数掘、随访记录)，数据以标准化格式(如SPSS、CSV文件)交付，共享范围不包含可识别个人身份的信息，使用方需遵守数据保密及合理使用协议。

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

The original data from this study will be made available for reasonable sharing with external researchers in accordance with academic standards after the publication of the study results. External parties must submit a written request for data use (including research purpose, scope of use, and a data confidentiality commitment) to the research team. After approval, de-identified raw data (with personally identifiable information removed, while retaining anonymized test data and follow-up records that remain traceable) will be provided in standardized formats (e.g., SPSS, CSV files). The shared data will not include any personally identifiable information, and the requesting party is required to comply with the data confidentiality and fair use agreement.

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：

1）数据记录工具 专门为本研究设计了病例报告表（CRF）进行记录，内容包括受试者的基本信息（包括性别、年龄、身高、体重）、既往史（吸烟史、高血压和糖尿病等全身性疾病病史、用药史、手术史、确诊甲状腺功能异常病史、确诊TAO病史）、临床检查结果（视力及验光结果、甲状腺功能检查、CAS评分、眼压、眼球突出度、视野、同视机、双眼视功能检查、眼位照相）、评分表（生活质量评估问卷）、影像学检查（眼眶CT检查）。所有参与研究人员均接受统一培训，确保对各指标的定义、测量方法和记录要求理解一致。 2）数据录入与核对 各中心指定专人负责数据录入工作。优先使用电子数据采集系统（EDC）进行数据录入，提高数据收集的效率和质量，并通过设置数据验证规则和逻辑检查，及时发现和纠正录入错误，保证数据的真实性和可靠性。暂无条件使用EDC者可采用纸质CRF记录，后续录入至牵头单位统一提供的电子数据模板，数据录入采用双人独立录入+交叉核对模式，即由两人分别录入同一份数据，完成后进行比对，发现不一致时及时溯源原始记录进行更正。无论采用何种录入方式，录入工作均应在每次随访完成后1周内完成。 3）数据核查与质控 各中心负责人对本科室数据的真实性和完整性负责。CRF提交前，应由指定人员对照原始病历完成关键指标的核对，确认无误后签字确认。 牵头单位定期组织数据质量抽查，原则上每3个月进行一次，每次抽查比例不低于各中心入组病例数的20%。抽查内容包括数据完整性、与原始记录的一致性及方案依从性。发现问题时，牵头单位出具书面反馈意见，相关中心应在2周内完成核实并反馈修正结果。 4）数据清洗与疑问处理 统计分析前，由统计人员对汇总数据库进行逻辑核查，重点筛查缺失值、异常值及逻辑矛盾（如手术日期早于入组日期）。发现疑问数据时，通过书面疑问表返回相应中心，由研究者查阅原始记录后补充或更正。所有数据修改过程均需留痕，确保可追溯。 5）缺失数据处理 对于关键指标的缺失，首先联系中心核实补充。确认为无法获取的缺失数据，将在分析前评估其缺失类型（完全随机缺失、随机缺失或非随机缺失），具体处理方法详见研究方案第5.3节。 6）数据安全与保存 所有研究资料（包括原始病历、CRF、影像资料、电子数据库）由各中心妥善保管。电子数据定期备份（建议每周增量备份、每月全量备份），防止丢失。研究结束后，相关资料按照临床试验管理要求保存至少5年。受试者身份信息在数据分析时进行脱敏处理，保护受试者隐私。

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

1) Data Recording ToolsA Case Report Form (CRF) was specifically designed for this study to record data, including subjects’ basic information (gender, age, height, weight), medical history (smoking history, history of systemic diseases such as hypertension and diabetes, medication history, surgical history, confirmed history of thyroid dysfunction, confirmed history of TAO), clinical examination results (visual acuity and refraction results, thyroid function tests, CAS score, intraocular pressure, proptosis, visual field, synoptophore, binocular vision function tests, ocular alignment photography), scoring scales (quality of life questionnaire), and imaging examinations (orbital CT). All participating researchers received standardized training to ensure a consistent understanding of the definitions, measurement methods, and recording requirements for each indicator.2) Data Entry and VerificationEach center designated a specific person responsible for data entry. An Electronic Data Capture (EDC) system was prioritized to improve the efficiency and quality of data collection, with data validation rules and logic checks to promptly identify and correct entry errors, ensuring data authenticity and reliability. For centers temporarily unable to use the EDC, paper CRFs were used, and data were subsequently entered into the unified electronic data template provided by the lead center. A double-entry with independent entry by two individuals followed by cross-verification was adopted: two persons entered the same data separately, and after completion, the entries were compared. Any inconsistencies were corrected by tracing back to the original records. Regardless of the method used, data entry was completed within one week after each follow-up visit.3) Data Verification and Quality ControlEach center’s principal investigator was responsible for the authenticity and completeness of the data at their site. Before submission, designated personnel verified key indicators against the original medical records, and confirmed accuracy with their signature. The lead center conducted regular data quality audits, every three months, sampling no less than 20% of enrolled cases from each center. The audit covered data completeness, consistency with original records, and protocol compliance. If issues were identified, the lead center issued written feedback, and the relevant center completed verification and submitted corrections within two weeks.4) Data Cleaning and Query ResolutionPrior to statistical analysis, statisticians performed logic checks on the pooled database, focusing on missing values, outliers, and logical inconsistencies (e.g., surgery date earlier than enrollment date). When questionable data were found, a written query form was sent to the corresponding center, and the investigator supplemented or corrected the data after reviewing the original records. All data modifications were documented to ensure traceability.5) Handling of Missing DataFor missing key indicators, the center was first contacted to verify and supplement the data. If the data were confirmed to be unobtainable, the type of missingness (missing completely at random, missing at random, or not missing at random) was assessed prior to analysis. Specific handling methods are detailed in Section 5.3 of the study protocol.6) Data Security and StorageAll study materials (including original medical records, CRFs, imaging data, and electronic databases) were properly stored by each center. Electronic data were regularly backed up (recommended weekly incremental backups and monthly full backups) to prevent loss. After the study concluded, relevant materials were kept for at least five years in accordance with clinical trial management requirements. Subject identity information was de-identified during data analysis to protect participant privacy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-01 22:04:13
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