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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.
時間枠：Baseline, 1 month post-surgery
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Baseline, 1 month post-surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-reported consistency between surgical outcomes and expectations
時間枠：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
時間枠：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
時間枠：Baseline, 1 month post-surgery
|
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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026KYPJ063
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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