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Ophthalmic AI-Assisted Medical Decision-Making 100.000 Multicêntrico
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06755060 é um estudo intervencionista para Ocular Diseases. Seu status atual é: em recrutamento. O estudo começou em 1 de dezembro de 2024 e pretende incluir 100.000 participantes. Coordenado por The Eye Hospital of Wenzhou Medical University e deve ser concluído em 30 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de agosto de 2025.
Resumo
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.
Descrição detalhada
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...Mostrar mais
Título oficial
A Study on Ophthalmic Multimodal AI-Assisted Medical Decision-Making Based on Imaging and Electronic Medical Record Data
Condições médicas
Ocular DiseasesOutros IDs do estudo
- Ophthalmic AI
Número NCT
Data de início (real)
2024-12-01
Última atualização postada
2025-08-20
Data de conclusão (estimada)
2026-12-30
Inscrição (estimada)
100.000
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
ocular diseases
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalAI-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...Mostrar mais |
Nenhuma intervençãoTraditional 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. | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- 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 UniversityResponsável pelo estudo
Kang Zhang, Investigador principal, Chief Scientist, The Eye Hospital of Wenzhou Medical University
Contato central do estudo
Contato: Lan Wang, MD, +86-0577-85397527, [email protected]
5 Locais do estudo em 2 países
Guangdong
ZhuHai Hospital, Zhuhai, Guangdong, China
Bingzhou Li, Contato, +86-0756-2222569, [email protected]
Em recrutamento
Zhejiang
First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Cheng Tang, MD, Contato, +86-0577-55579999, [email protected]
Em recrutamento
Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Sian Liu, PhD., Contato, +86-0577-88002888, [email protected]
Em recrutamento
The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Lan Wang, MD, Contato, +86-0577-85397527, [email protected]
Kang Zhang, PhD., Investigador principal
Em recrutamento
Macau University of Science and Technology Hospital, Macao, Macau
Yang Liu, MD, Contato, +853-2882-1838, [email protected]
Em recrutamento