임상 레이더 AI | ||
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임상시험 NCT06755060은(는) Ocular Diseases에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Ophthalmic AI-Assisted Medical Decision-Making 100,000 다기관
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06755060은(는) Ocular Diseases에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2024년 12월 1일에 시작되어 100,000명의 참여자를 모집하고 있습니다. The Eye Hospital of Wenzhou Medical University이(가) 진행하며, 2026년 12월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 8월 20일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...더 보기
공식 제목
A Study on Ophthalmic Multimodal AI-Assisted Medical Decision-Making Based on Imaging and Electronic Medical Record Data
질환명
Ocular Diseases기타 연구 식별자
- Ophthalmic AI
NCT 번호
실제 연구 시작일
2024-12-01
최신 업데이트 게시
2025-08-20
예상 연구 완료일
2026-12-30
계획된 등록 인원
100,000
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
ocular diseases
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
Ophthalmic Multimodal AI-Assisted Medical Decision-Making
Artificial Intelligence
주요 목적
기타
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적AI-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...더 보기 |
비개입Traditional 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. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
참여 가능한 성별
전체
건강한 참가자 허용
네
- 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 University연구 책임자
Kang Zhang, 책임연구자, Chief Scientist, The Eye Hospital of Wenzhou Medical University
연구 대표 연락처
연락처: Lan Wang, MD, +86-0577-85397527, [email protected]
5 2개국에 임상시험 장소
Guangdong
Zhejiang
First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Cheng Tang, MD, 연락처, +86-0577-55579999, [email protected]
모집중
Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Sian Liu, PhD., 연락처, +86-0577-88002888, [email protected]
모집중
The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Lan Wang, MD, 연락처, +86-0577-85397527, [email protected]
Kang Zhang, PhD., 책임연구자
모집중
Macau University of Science and Technology Hospital, Macao, Macau
Yang Liu, MD, 연락처, +853-2882-1838, [email protected]
모집중