OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
A Randomized Controlled Trial Comparing the Accuracy of the Postoperative Vision Prediction Model for Cataract Surgery (OCT-PRO) With Clinicians' Predictions of Surgical Outcomes
연구 개요
상세 설명
Cataract is the leading cause of blindness worldwide, yet 5-20% of patients fail to achieve satisfactory visual recovery after surgery. Accurate preoperative prediction remains challenging, particularly for eyes with co-morbid retinal pathologies, as current methods relying on clinician experience and traditional tests (e.g., laser interferometry) often lack reproducibility. Although AI models like OCT-PRO show promise, prospective RCT evidence comparing their accuracy against clinicians is lacking.
This multi-center, randomized, assessor-blinded trial will enroll 534 adults scheduled for cataract surgery. Participants are allocated 1:1 to either the Experimental Group or the Control Group via centralized randomization. In the Experimental Group, clinicians use the OCT-PRO model-integrating OCT images and clinical data-to obtain a predicted postoperative BCVA. Physicians may confirm or adjust this prediction, and the final value is communicated to patients during preoperative counseling. The Control Group receives standard care, where predictions are based solely on conventional clinical assessments without AI assistance. Outcome assessors will be blinded to group allocation.
The primary endpoint is the Mean Absolute Error (MAE) between predicted and actual postoperative BCVA. Secondary endpoints include patient-reported outcomes (expectations, informed choice, satisfaction), clinician acceptance of the model, and correlation analyses. Analysis will follow the Intention-to-Treat principle. This study aims to provide high-level evidence on integrating AI into clinical workflows to enhance prognostic accuracy and optimize shared decision-making in cataract surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years scheduled to undergo phacoemulsification with intraocular lens (Phaco+IOL) implantation.
- Outpatient diagnosis of senile, complicated, or metabolic cataract.
- For bilateral cataracts, the eye with more advanced disease will be included.
Exclusion Criteria:
- History of amblyopia or neuro-ophthalmic disease in the operative eye.
- Poor-quality OCT images precluding clear visualization of fundus structures.
- Previous intraocular surgery in the operative eye.
- Hearing or intellectual impairment preventing adequate cooperation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: OCT-PRO Assisted Prediction
Clinicians input preoperative OCT images and clinical data into the OCT-PRO model to generate a predicted postoperative BCVA.
Physicians may confirm or adjust this AI prediction to determine a final value.
This final prediction value is then communicated to the patient as supplementary information during routine preoperative counseling.
|
The OCT-PRO model integrates optical coherence tomography (OCT) images and clinical data to predict postoperative best-corrected visual acuity (BCVA).
In the experimental group, clinicians input preoperative data into the model, confirm or adjust the prediction, and communicate the final value to patients during preoperative counseling.
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활성 비교기: Routine Clinical Prediction
Clinicians perform standard preoperative assessments based on clinical experience and examination results.
Predictions of postoperative visual acuity are made solely by physician judgment without AI assistance.
Patients receive routine preoperative counseling regarding surgical risks and expected outcomes.
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Standard preoperative communication based on clinical experience and conventional examinations without AI assistance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.
기간: Baseline, 1 month post-surgery
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Baseline, 1 month post-surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-reported consistency between surgical outcomes and expectations
기간: Baseline, 1 month post-surgery
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Patient-perceived alignment between actual surgical outcomes and preoperative expectations, measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
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Patient-reported psychological impact of preoperative prognostic disclosure
기간: Baseline, 1 month post-surgery
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Psychological response to receiving preoperative prognostic information (e.g., anxiety, reassurance), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
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Patient-reported willingness to recommend prognostic information to others
기간: Baseline, 1 month post-surgery
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Willingness to recommend cataract surgery prognostic information to others (e.g., family or friends), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
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Patient-reported satisfaction with healthcare services
기간: Baseline, 1 month post-surgery
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Patient satisfaction with overall healthcare services received during cataract surgery (e.g., communication, care quality, information clarity), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
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Clinician-reported outcomes assessing the satisfaction of using OCT-PRO in cataract treatment decision-making
기간: Baseline, 1 month post-surgery
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Clinician-reported satisfaction with incorporating OCT-PRO into preoperative decision-making (e.g., ease of use, confidence in prediction, communication aid), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
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Correlation coefficients (Pearson/Spearman) between predicted and actual BCVA in both groups
기간: From before surgery to 1 month (±1 week) post-surgery
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From before surgery to 1 month (±1 week) post-surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026KYPJ063
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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OCT-PRO prediction model에 대한 임상 시험
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Instituto Universitario de Oftalmobiología Aplicada...Hospital del Rio Hortega; Fundación Eugenio Rodríguez Pascual초대로 등록
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University College, London모병심혈관 질환 | 위암 | 대장암 | 췌장암 | 심장 독성 | 강한 악의 | 식도암 | 플루오로우라실 이상반응영국
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The Filatov Institute of Eye Diseases and Tissue...Odessa National Medical University; Mykolaiv Region Ophthalmogical Hospital; Central Polyclinic...완전한
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The Filatov Institute of Eye Diseases and Tissue...Odessa National Medical University; Mykolaiv Region Ophthalmogical Hospital; Central Polyclinic...알려지지 않은