ChiCTR2600117156 版本V1.0 版本创建时间2026/01/20 16:14:45 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：

ChiCTR2600117156 

最近更新日期：

Date of Last Refreshed on：

2026-01-20 16:14:31 

注册时间：

Date of Registration：

2026-01-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

三种不同培训模式对白内障手术初学者连续环形撕囊（CCC）教学效果的比较研究

Public title：

A Comparative Study on the Teaching Effectiveness of Three Different Training Models for Continuous Circular Capsulorhexis (CCC) Among Cataract Surgery Beginners

注册题目简写：

English Acronym：

研究课题的正式科学名称：

三种不同培训模式对白内障手术初学者连续环形撕囊（CCC）教学效果的比较研究

Scientific title：

A Comparative Study on the Teaching Effectiveness of Three Different Training Models for Continuous Circular Capsulorhexis (CCC) Among Cataract Surgery Beginners

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：

张娟 

研究负责人：

毕燕龙,张娟 

Applicant：

Juan Zhang 

Study leader：

Bi Yanlong, Juan Zhang 

申请注册联系人电话：

Applicant telephone：

+86 158 8049 9969

研究负责人电话：

Study leader's telephone：

+86 158 8049 9969

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：

juanzhang0812@163.com

研究负责人电子邮件：

Study leader's E-mail：

juanzhang0812@163.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：

上海市普陀区新村路389号

研究负责人通讯地址：

上海市普陀区新村路389号

Applicant address：

No. 389, Xincun Road, Putuo District, Shanghai

Study leader's address：

No. 389, Xincun Road, Putuo District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200065

研究负责人邮政编码：

Study leader's postcode：

200065

申请人所在单位：

同济大学附属同济医院

Applicant's institution：

Tongji Hospital Affiliated with Tongji University

研究负责人所在单位：

同济大学附属同济医院/上海市同济医院

Affiliation of the Leader：

Tongji Hospital Affiliated with Tongji University/Shanghai Tongji Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(同)伦审第(K-2026-009)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：

上海市同济医院伦理委员会

Name of the ethic committee：

Shanghai Tongji Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-12 00:00:00

伦理委员会联系人：

宣淼

Contact Name of the ethic committee：

Miao Xuan

伦理委员会联系地址：

上海市普陀区新村路389号

Contact Address of the ethic committee：

No. 389, Xincun Road, Putuo District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6611 1243

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：

同济大学附属同济医院

Primary sponsor：

Tongji Hospital Affiliated with Tongji University

研究实施负责（组长）单位地址：

上海市普陀区新村路389号

Primary sponsor's address：

No. 389, Xincun Road, Putuo District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

ShangHai

City：

单位(医院)：

同济大学附属同济医院

具体地址：

上海市普陀区新村路389号

Institution
hospital：

Tongji Hospital Affiliated to Tongji University

Address：

No. 389, Xincun Road, Putuo District, Shanghai

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Cataracts

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：

比较白内障撕囊模型、葡萄模拟撕囊以及猪眼球模拟撕囊这三种培训方式，对于眼科住院医师连续环形撕囊技能培养的教学成效，旨在为构建规范化、阶梯式的显微手术培训课程提供参考依据。  

Objectives of Study：

Compare the teaching effectiveness of three training methods—cataract capsulorhexis models, grape simulated capsulorhexis, and porcine eyeball simulated capsulorhexis—in cultivating continuous curvilinear capsulorhexis skills among ophthalmology residents. The aim is to provide a reference for establishing a standardized, step-by-step microsurgical training curriculum.

药物成份或治疗方案详述：

采用前瞻性、随机对照、评估者盲法的三臂研究设计。于2022年8月至2024年7月，连续纳入某眼科中心45名已完成基础理论培训的住院医师，随机分配至模拟器组、葡萄组与猪眼组，每组15人。所有学员在为期3个月的标准化周期内完成等强度的训练。主要结局指标为基于GRASIS量表（操作流畅性、器械操作、组织处理）与ICO-OSCAR撕囊专项评估（起始瓣制作、圆形完成度与连续性）整合而成的《连续环形撕囊技能结构化评分表》，总分35分。所有操作均录像，由两名经过统一校准且不知分组的高级医师独立完成双盲评分。次要结局指标包括客观操作时长、撕囊直径圆度（图像分析）、一次性成功率及培训前后自信心量表评分。评估于培训前（基线）、培训结束时及培训后1个月进行。 

Description for medicine or protocol of treatment in detail：

A prospective, randomized, triple-blind, three-arm study design was adopted. From August 2022 to July 2024, 45 residents who had completed basic theoretical training at an ophthalmic center were consecutively enrolled and randomly assigned to three groups: the simulator group, the grape group, and the porcine eye group, with 15 participants in each group. All trainees completed equal-intensity training over a standardized three-month period. The primary outcome measure was the **"Structured Assessment Scale for Continuous Curvilinear Capsulorhexis Skills"**, which integrates the GRASIS scale (fluency, instrument handling, tissue handling) and the ICO-OSCAR capsulorhexis-specific assessment (initial flap creation, circularity, and continuity), with a total score of 35 points. All procedures were video-recorded and independently scored by two senior ophthalmologists who were calibrated and blinded to the group assignments. Secondary outcome measures included objective operation time, capsulorhexis circularity (image analysis), one-time success rate, and pre- and post-training confidence scale scores. Assessments were conducted at baseline (before training), immediately after training, and one month after training completion. 

纳入标准：

入组学员为工作年限相似的眼科医师，有相似的显微手术 操作基础，可熟练操作显微镜、识别和使用白内障手术器械、显微镜下完成夹持、缝合、剪 线等操作，既往未参与过系统超声乳化白内障吸除术培训。

Inclusion criteria

The enrolled trainees are ophthalmologists with similar years of clinical experience, possessing comparable foundational microsurgical skills. They are proficient in operating the microscope, identifying and utilizing cataract surgical instruments, and performing tasks such as grasping, suturing, and cutting sutures under the microscope. None of them have previously undergone systematic training in phacoemulsification cataract extraction.

排除标准：

无法按时完成全程教学培训计划、无法参与教学培训后评估、既往参与过超声乳化白内障吸除术培训。

Exclusion criteria：

Unable to complete the entire teaching and training plan as scheduled, unable to participate in post-training assessments, or having previously undergone training in phacoemulsification cataract extraction.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-01 00:00:00 至 To 2026-05-31 00:00:00  

干预措施：

Interventions：

组别：

模拟器组

样本量：

15

Group：

Simulator group

Sample size：

干预措施：

所有学员在为期3个月的标准化周期内完成等强度的训练，用撕囊模拟器模拟撕囊。主要结局指标为基于GRASIS量表（操作流畅性、器械操作、组织处理）与ICO-OSCAR撕囊专项评估（起始瓣制作、圆形完成度与连续性）整合而成的《连续环形撕囊技能结构化评分表》，总分35分。所有操作均录像，由两名经过统一校准且不知分组的高级医师独立完成双盲评分。次要结局指标包括客观操作时长、撕囊直径圆度（图像分析）、一次性成功率及培训前后自信心量表评分。评估于培训前（基线）、培训结束时及培训后1个月进行。

干预措施代码：

Intervention：

All trainees completed training of equal intensity over a standardized 3-month period using a capsulorhexis simulator. The primary outcome measure was the **Structured Assessment Scale for Continuous Curvilinear Capsulorhexis Skills**, which integrates the GRASIS scale (Fluency, Instrument Handling, Tissue Handling) and the ICO-OSCAR capsulorhexis-specific assessment (Initial Flap Creation, Circularity, and Continuity), with a total score of 35 points. All procedures were video-recorded and independently double-blinded scored by two senior ophthalmologists who were uniformly calibrated and unaware of the group assignments. Secondary outcome measures included objective operation time, capsulorhexis circularity (image analysis), one-time success rate, and pre- and post-training confidence scale scores. Assessments were conducted at baseline (before training), immediately after training completion, and one month after training.

Intervention code：

组别：

葡萄组

样本量：

15

Group：

Grape group

Sample size：

干预措施：

所有学员在为期3个月的标准化周期内完成等强度的训练，用葡萄模拟撕囊。主要结局指标为基于GRASIS量表（操作流畅性、器械操作、组织处理）与ICO-OSCAR撕囊专项评估（起始瓣制作、圆形完成度与连续性）整合而成的《连续环形撕囊技能结构化评分表》，总分35分。所有操作均录像，由两名经过统一校准且不知分组的高级医师独立完成双盲评分。次要结局指标包括客观操作时长、撕囊直径圆度（图像分析）、一次性成功率及培训前后自信心量表评分。评估于培训前（基线）、培训结束时及培训后1个月进行。

干预措施代码：

Intervention：

All trainees completed training of equal intensity over a standardized 3-month period using grape models for capsulorhexis simulation. The primary outcome measure was the **Structured Assessment Scale for Continuous Curvilinear Capsulorhexis Skills**, which integrates the GRASIS scale (Fluency, Instrument Handling, Tissue Handling) and the ICO-OSCAR capsulorhexis-specific assessment (Initial Flap Creation, Circularity, and Continuity), with a total score of 35 points. All procedures were video-recorded and independently double-blinded scored by two senior ophthalmologists who were uniformly calibrated and unaware of the group assignments. Secondary outcome measures included objective operation time, capsulorhexis circularity (image analysis), one-time success rate, and pre- and post-training confidence scale scores. Assessments were conducted at baseline (before training), immediately after training completion, and one month after training.

Intervention code：

组别：

猪眼组

样本量：

15

Group：

Porcine eye group

Sample size：

干预措施：

所有学员在为期3个月的标准化周期内完成等强度的训练，用猪眼拟撕囊。主要结局指标为基于GRASIS量表（操作流畅性、器械操作、组织处理）与ICO-OSCAR撕囊专项评估（起始瓣制作、圆形完成度与连续性）整合而成的《连续环形撕囊技能结构化评分表》，总分35分。所有操作均录像，由两名经过统一校准且不知分组的高级医师独立完成双盲评分。次要结局指标包括客观操作时长、撕囊直径圆度（图像分析）、一次性成功率及培训前后自信心量表评分。评估于培训前（基线）、培训结束时及培训后1个月进行。

干预措施代码：

Intervention：

All trainees completed training of equal intensity over a standardized 3-month period using porcine eyes for capsulorhexis simulation. The primary outcome measure was the **Structured Assessment Scale for Continuous Curvilinear Capsulorhexis Skills**, which integrates the GRASIS scale (Fluency, Instrument Handling, Tissue Handling) and the ICO-OSCAR capsulorhexis-specific assessment (Initial Flap Creation, Circularity, and Continuity), with a total score of 35 points. All procedures were video-recorded and independently double-blinded scored by two senior ophthalmologists who were uniformly calibrated and unaware of the group assignments. Secondary outcome measures included objective operation time, capsulorhexis circularity (image analysis), one-time success rate, and pre- and post-training confidence scale scores. Assessments were conducted at baseline (before training), immediately after training completion, and one month after training.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China 

Province：

ShangHai 

City：

 

单位(医院)：

同济大学附属同济医院 

单位级别：

三甲 

Institution
hospital：

Tongji Hospital Affiliated to Tongji University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

基于《连续环形撕囊技能结构化评分表》（整合GRASIS量表与ICO-OSCAR专项评估）的总分

指标类型：

主要指标

Outcome：

Total score based on the 'Structured Scoring Table for Continuous Circular Capsulorhexis Skills' (integrating the GRASIS scale and ICO-OSCAR specialized assessment)

Type：

Primary indicator

测量时间点：

3个月的标准化周期

测量方法：

所有操作均录像，由两名经过统一校准且不知分组的高级医师独立完成双盲评分。

Measure time point of outcome：

a standardized 3-month cycle

Measure method：

All procedures were video-recorded and independently double-blinded scored by two senior ophthalmologists who were uniformly calibrated and unaware of the group assignments.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

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）：

本研究采用完全随机化设计，将受试者按1:1：1比例分配至三组。具体流程如下：首先在STATBox统计软件中生成与总样本量相等的一系列随机数，依据随机数结果将每位受试者分配至相应组别，形成不可预测的随机分配序列；随后通过密封信封或中央随机系统对该分配序列进行隐藏。受试者入组时，严格依照隐藏序列顺序执行分组，从而排除主观因素干扰，确保三组基线特征均衡，有效控制选择偏倚。采用随机数字表法，将符合纳入标准的学员以1:1:1的比例随机分配至以下三组： 模拟器组：使用眼科虚拟手术模拟器（如Virtea等）进行培训。 葡萄组：使用带皮葡萄模型进行培训。 猪眼组：使用新鲜猪眼球模型进行培训。

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

This study employed a completely randomized design, allocating participants to three groups in a 1:1:1 ratio. The specific procedure was as follows: first, a series of random numbers equal to the total sample size was generated using STATBox statistical software. Based on the results of these random numbers, each participant was assigned to a corresponding group, forming an unpredictable random allocation sequence. This sequence was then concealed using sealed envelopes or a central randomization system. Upon enrollment, participants were strictly assigned to groups according to the concealed sequence, thereby eliminating subjective interference, ensuring balanced baseline characteristics across the three groups, and effectively controlling for selection bias. Using a random number table method, eligible trainees were randomized in a 1:1:1 ratio into the following three groups: - Simulator group: Training using ophthalmic virtual surgical simulators (e.g., Virtea, etc.). - Grape group: Training using grape models with skin. - Porcine eye group: Training using fresh porcine eyeball models.

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：

1. 随机序列隐藏 采用?STATBox软件生成随机数，形成不可预测的分组序列。 通过?密封信封或中央随机系统?隐藏分配序列，确保分组过程不可预知。 2. 分组执行 受试者入组时，严格按隐藏序列分配至三组（模拟器组、葡萄组、猪眼组）。 受试者知晓自身所用培训模型（因操作材料不同），但不被告知其他组别信息及研究假设。 3. 评估阶段设盲 所有操作全程录像，视频文件隐去任何可识别分组的信息（如模型特征、界面标识等）。 两名经过统一校准的高级医师独立评分，且： 不知晓分组方案； 不知晓视频对应的组别或受试者身份； 不接受与研究设计者的沟通，确保评分独立。 评分数据由第三方研究人员（非评估者）汇总，确保分析前评估者无法接触分组信息。

Blinding：

1. The random sequence is generated by STATBox software to create unpredictable grouping patterns. The allocation sequence is hidden by a sealed envelope or a central random system to ensure that the grouping process is unpredictable. 2. Group assignment During subject enrollment, participants were strictly allocated to three groups (simulator group, grape group, and pig eye group) according to the concealed sequence. Participants were aware of the training model they were using (due to differences in operational materials), but were not informed of information about other groups or the study hypothesis. 3. During the evaluation phase, all procedures are recorded with blind settings, and the video files are anonymized to remove any identifiable grouping information (e.g., model features, interface identifiers, etc.). The scores were independently assessed by two senior physicians who underwent unified calibration, with the following conditions: unaware of the grouping protocol; unaware of the group or subject identity corresponding to the video; and no communication with the study designer to ensure independent scoring. The scoring data was aggregated by third-party researchers (non-assessors) to ensure that assessors had no access to the grouping information prior to analysis.

是否共享原始数据：

IPD sharing

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：

电子采集和管

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

Electronic Data Captur

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：

  2026-01-20 16:14:31