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临床试验 NCT06755060 针对Ocular Diseases目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Ophthalmic AI-Assisted Medical Decision-Making 100,000 多中心
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临床试验NCT06755060是一项针对Ocular Diseases的干预性研究试验，目前试验状态为招募中。试验始于2024年12月1日，计划招募100,000名患者。该研究由The Eye Hospital of Wenzhou Medical University主导，预计于2026年12月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年8月20日。
简要概括
This is a multi-center, prospective clinical study designed to evaluate the application and effectiveness of an AI-assisted medical decision support system, leveraging multimodal data fusion, in ophthalmic clinical practice.
详细描述
Visual impairments significantly affect an individual's quality of life. Early screening, diagnosis, and treatment of ocular diseases are crucial for preventing the onset and progression of vision disorders. In clinical practice, ophthalmologists often need to integrate a wide range of patient data, including demographic information, medical history, biochemical markers such as blood glucose and lipid levels, risk fa...显示更多
官方标题
A Study on Ophthalmic Multimodal AI-Assisted Medical Decision-Making Based on Imaging and Electronic Medical Record Data
疾病
Ocular Diseases其他研究标识符
- Ophthalmic AI
NCT编号
实际开始日期
2024-12-01
最近更新发布
2025-08-20
预计完成日期
2026-12-30
计划入组人数
100,000
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
ocular diseases
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
主要目的
其他
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性AI-assisted medical decision-making Patients in the intervention group will receive AI-assisted medical decision-making based on multimodal data. | AI-associated strategy The intervention in this study involves an AI system that leverages multimodal data fusion to support the clinical decision-making and evaluation of ophthalmic diseases. Patients in the intervention group will undergo standard ophthalmic examinations, with clinical decisions guided by the recommendations generated by the AI system. In contrast, patients in the control group will receive only standard ophthalmic exami...显示更多 |
无干预Traditional medical decision-making Patients in the control group will receive traditional medical decision-making, where treatment and diagnostic decisions are made solely by the attending physician based on clinical judgment, without the support of AI-assisted system. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Area Under the Curve (AUC) | AUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1). | 2 years |
Sensitivity | Sensitivity (also called True Positive Rate) is a measure of how well a model identifies positive instances. It is defined as the proportion of actual positive cases correctly identified by the model. No unit (a ratio or percentage, typically expressed as a percentage). | 2 years |
Specificity | Specificity (also called True Negative Rate) measures the proportion of actual negative cases correctly identified by the model. No unit (a ratio or percentage, typically expressed as a percentage). | 2 years |
Accuracy | Accuracy measures the proportion of all correct predictions (true positives and true negatives) out of the total number of cases evaluated by the model. No unit (a ratio or percentage, typically expressed as a percentage). | 2 years |
False Positive Rate | False Positive Rate (FPR) measures the proportion of actual negative cases that are incorrectly identified as positive by the model. No unit (a ratio or percentage, typically expressed as a percentage). | 2 years |
False Negative Rate | False Negative Rate (FNR) measures the proportion of actual positive cases that are incorrectly identified as negative by the model. No unit (a ratio or percentage, typically expressed as a percentage). | 2 years |
Postoperative Complication Rate | Percentage (%) of patients experiencing postoperative complications. | 2 years |
Recurrence Risk Rate | Percentage (%) of patients experiencing recurrence during the follow-up period. | 2 years |
Survival Rate | Percentage (%) of patients alive, calculated using Kaplan-Meier survival curves. | 2 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
System Usability Score | Evaluated using the System Usability Scale (SUS), with scores ranging from 0-100. | 2 years |
AI System Response Time | Average time (seconds) taken for the AI to provide recommendations after data input. | 2 years |
System Failure Rate | Frequency of AI system failures, measured as failures per thousand hours of use (failures/thousand hours). | 2 years |
User Interface Design Satisfaction | Evaluated using the User Experience Questionnaire (UEQ), with scores ranging from 1-7. | 2 years |
Patient Satisfaction Score | Measured using the Patient Satisfaction Questionnaire (CSQ-8), with scores ranging from 8-32. | 2 years |
Treatment Adherence | Percentage (%) of patients adhering to personalized treatment plans and regular follow-up visits. | 2 years |
Physician Acceptance of AI System | Evaluated using the Technology Acceptance Model (TAM) scale, with scores ranging from 1-7. | 2 years |
Effectiveness of Decision Support | Percentage (%) improvement in the accuracy of treatment decisions with AI assistance compared to traditional decisions. | 2 years |
Decision Time Efficiency | Average time (seconds) required for physicians to make diagnostic and treatment decisions, before and after AI assistance. | 2 years |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
适龄性别
全部
接受健康志愿者
是
- Age Criteria: No age restrictions apply for inclusion in the study.
- Ophthalmic Disease Diagnosis: Eligible patients must have a diagnosis of one or more ophthalmic conditions, with the diagnosis confirmed by a qualified ophthalmologist.
- Imaging and Clinical Data Requirements: Patients must be able to provide complete ophthalmic imaging data and electronic medical records (EMR) that are comprehensive and accessible for the purposes of the study.
- Informed Consent: All patients, or their legal representatives in the case of minors or individuals unable to provide informed consent, must sign a consent form that clearly outlines the study's objectives, procedures, potential risks and discomforts, data usage, and the rights and responsibilities of participants. In the case of minors or those unable to consent, informed consent must be obtained from the patient's legal guardian.
- Treatment Adherence: Participants must demonstrate the ability to understand and adhere to the study's requirements, including compliance with follow-up visits, examination schedules, and treatment recommendations. Patients must agree to participate in regular assessments and data collection, including imaging exams, laboratory tests, and follow-up evaluations as required by the study protocol.
- Clinical Physician Assessment: The attending physician must determine that the patient meets all inclusion criteria and has the capacity to comply with the necessary treatment, diagnostic tests, and follow-up protocols throughout the study duration.
- Acute or Severe Ocular Diseases: Patients with acute ocular conditions requiring immediate medical intervention, which necessitate exclusion from interventional studies due to the urgency of their treatment.
- Serious Systemic Diseases: Patients with serious systemic illnesses that may interfere with the treatment of ocular diseases, impact the effectiveness of the intervention, or complicate the interpretation of study outcomes.
- Prior Exposure to Study Interventions: Patients who have previously undergone the intervention being studied or participated in other experimental treatments within ongoing clinical trials, as this may introduce bias or confound the study results.
- Incomplete Imaging or Clinical Data: Patients who are unable to provide complete or adequate ophthalmic imaging data or lack a comprehensive electronic medical record (EMR), which are essential for the integrity of the study data.
- Pregnancy or Lactation: Pregnant or breastfeeding women, for whom there may be potential risks associated with ocular treatment or imaging procedures. Such cases will be evaluated on an individual basis to ensure patient safety.
- Mental Health or Cognitive Impairment: Patients diagnosed with significant mental health disorders or cognitive impairments that prevent them from fully understanding the nature and risks of the study, or from complying with the treatment regimen and follow-up procedures.
- Drug Allergies or Severe Reactions: Patients with known allergies or severe adverse reactions to any medications or ophthalmic treatments likely to be used during the study, which could pose a health risk to the patient.
- Current Participation in Other Clinical Trials: Patients who are concurrently involved in other interventional clinical trials (especially those related to ophthalmology), as this may lead to conflicting treatments or interfere with the assessment of the study's outcomes.
- Inability to Comply with Follow-up Requirements: Patients who, due to logistical, health-related, or personal factors, are unable to comply with the required follow-up visits, treatment regimens, or data collection, which are essential for the study's longitudinal analysis.
- Other Clinical Exclusions: Patients whose participation, based on the clinical judgment of the treating physician, may not be in their best interest due to their health condition or other factors, or who may experience adverse outcomes from participating in the study.
The Eye Hospital of Wenzhou Medical University研究责任方
Kang Zhang, 主要研究者, Chief Scientist, The Eye Hospital of Wenzhou Medical University
研究中心联系人
联系人: Lan Wang, MD, +86-0577-85397527, [email protected]
5 位于 2 个国家/地区的研究中心
Guangdong
Zhejiang
First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Cheng Tang, MD, 联系人, +86-0577-55579999, [email protected]
招募中
Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Sian Liu, PhD., 联系人, +86-0577-88002888, [email protected]
招募中
The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Lan Wang, MD, 联系人, +86-0577-85397527, [email protected]
Kang Zhang, PhD., 主要研究者
招募中
Macau University of Science and Technology Hospital, Macao, Macau
Yang Liu, MD, 联系人, +853-2882-1838, [email protected]
招募中