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Lo studio clinico NCT06755060 per Ocular Diseases è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Ophthalmic AI-Assisted Medical Decision-Making 100.000 Multicentrico

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06755060 è uno studio interventistico per Ocular Diseases, attualmente in arruolamento. Avviato il 1 dicembre 2024, prevede di arruolare 100.000 partecipanti. Sotto la guida di The Eye Hospital of Wenzhou Medical University, dovrebbe concludersi entro il 30 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 agosto 2025.
Sommario breve
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.
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale

A Study on Ophthalmic Multimodal AI-Assisted Medical Decision-Making Based on Imaging and Electronic Medical Record Data

Patologie
Ocular Diseases
Altri ID dello studio
  • Ophthalmic AI
Numero NCT
NCT06755060
Data di inizio (effettiva)
2024-12-01
Ultimo aggiornamento pubblicato
2025-08-20
Data di completamento (stimata)
2026-12-30
Arruolamento (previsto)
100.000
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
ocular diseases
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleAI-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...Mostra di più
Nessun interventoTraditional 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.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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 alla partecipazione
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Sessi idonei
Tutti
Accetta volontari sani
Sì
  1. Age Criteria: No age restrictions apply for inclusion in the study.
  2. Ophthalmic Disease Diagnosis: Eligible patients must have a diagnosis of one or more ophthalmic conditions, with the diagnosis confirmed by a qualified ophthalmologist.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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 logoThe Eye Hospital of Wenzhou Medical University
Parte responsabile dello studio
Kang Zhang, Investigatore principale, Chief Scientist, The Eye Hospital of Wenzhou Medical University
Contatti principali dello studio
Contatto: Lan Wang, MD, +86-0577-85397527, [email protected]
5 Centri dello studio in 2 paesi

Guangdong

ZhuHai Hospital, Zhuhai, Guangdong, China
Bingzhou Li, Contatto, +86-0756-2222569, [email protected]
In arruolamento

Zhejiang

First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Cheng Tang, MD, Contatto, +86-0577-55579999, [email protected]
In arruolamento
Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Sian Liu, PhD., Contatto, +86-0577-88002888, [email protected]
In arruolamento
The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Lan Wang, MD, Contatto, +86-0577-85397527, [email protected]
Kang Zhang, PhD., Investigatore principale
In arruolamento
Macau University of Science and Technology Hospital, Macao, Macau
Yang Liu, MD, Contatto, +853-2882-1838, [email protected]
In arruolamento