AI-Driven IOL Prediction Using SS-OCT Biometry
International Multicenter Evaluation of a Novel SS-OCT Biometer and Development of an AI-Driven Intraocular Lens Power Prediction Model
This prospective, multicenter, non-interventional observational study aims to evaluate the agreement between a novel swept-source optical coherence tomography (SS-OCT) biometer and the IOLMaster 700 for ocular biometric measurements and to develop and validate an artificial intelligence (AI)-driven intraocular lens (IOL) power prediction model.
The primary research questions are:
Does the novel SS-OCT biometer provide ocular biometric measurements that are comparable to those obtained using the IOLMaster 700? Can an AI-driven IOL power prediction model developed from multicenter biometric, imaging, surgical, and postoperative refractive data improve the accuracy of postoperative refractive prediction?
Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification with posterior chamber IOL implantation will be consecutively recruited from participating study centers. Participants will undergo routine preoperative clinical assessments together with additional non-contact biometric measurements using the novel SS-OCT biometer before cataract surgery. Cataract surgery and postoperative care will follow standard clinical practice and will not be influenced by the study. Postoperative refractive and visual outcomes at approximately one month after surgery will be collected for analysis. The AI model and research device measurements will be used for research purposes only and will not be used to guide clinical decision-making during the study.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jijing Li
- 電話番号：+85247412617
- メール：jijing0306@gmail.com
研究場所
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Adelaide、オーストラリア
- Royal Adelaide Hospital (tentative)
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コンタクト：
- Cheung Wong
- 電話番号：8613714543967
- メール：cheung.p.wong@gmail.com
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Hebei
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Wuhan、Hebei、中国、430032
- Wuhan Purui Ophthalmology Hospital
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コンタクト：
- zhimin Huang
- 電話番号：8615007176939
- メール：625806284@qq.com
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Kowloon City、香港
- Hong Kong Eye Hospital
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コンタクト：
- Jijing Li
- 電話番号：85247412617
- メール：jijing0306@gmail.com
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Aged 18 years or above.
- Diagnosed with age-related cataract.
- Scheduled for routine phacoemulsification with posterior chamber intraocular lens implantation.
- Able to cooperate with preoperative ocular biometric measurements and postoperative assessments.
- Able to attend the planned 1-month postoperative follow-up visit.
- Able to understand the study information and provide written informed consent.
Exclusion Criteria:
- Ocular conditions that may significantly affect biometric measurements or postoperative refractive outcomes, including but not limited to severe corneal disease, severe ocular surface disease, advanced glaucoma, retinal detachment, severe maculopathy, significant optic nerve disease, or ocular trauma.
- History of previous intraocular surgery in the study eye, except minor superficial ocular procedures that are not expected to affect ocular biometry or refractive outcomes.
- Uncontrolled severe systemic disease that, in the opinion of the investigator or treating clinician, makes the patient unsuitable for routine cataract surgery or study participation.
- Cognitive impairment, severe mental disorder, or other condition that prevents the participant from understanding the study or providing valid informed consent.
- Poor cooperation that prevents reliable ocular biometric measurement or follow-up assessment.
- Current participation in another interventional clinical study that may affect the outcomes of this study.
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
コホートと介入
グループ/コホート |
介入・治療 |
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Cataract Surgical Participants
All adult participants diagnosed with age-related cataract scheduled for routine phacoemulsification and IOL implantation.
All subjects receive parallel preoperative ocular biometry scans with IOLMaster 700 and a novel investigational SS-OCT biometer, followed by 1-month postoperative refractive follow-up.
No clinical treatment assignment is altered for research purposes.
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Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care.
Investigational prototype swept-source OCT biometer for research-only parallel measurement of ocular biometric parameters; results will not be used to determine clinical IOL power selection.
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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 |
メジャーの説明 |
時間枠 |
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Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700
時間枠：Preoperatively (single measurement visit before cataract surgery)
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Bland-Altman 95% limits of agreement, mean difference, intraclass correlation coefficient (ICC) for six key biometric parameters: axial length, keratometry, anterior chamber depth, lens thickness, central corneal thickness, white-to-white diameter
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Preoperatively (single measurement visit before cataract 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 |
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Measurement success rate of two biometers
時間枠：Preoperatively
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Percentage of valid, analyzable scans obtained from Novel SS-OCT Biometer vs IOLMaster 700
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Preoperatively
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Refractive prediction error of AI-driven IOL power model
時間枠：1 month postoperatively
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Mean absolute error (MAE), median absolute error (MedAE), root mean square error (RMSE); proportion of eyes within ±0.5D / ±1.0D refractive prediction error
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1 month postoperatively
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AI model performance across multi-ethnic cohorts
時間枠：1 month postoperatively
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Stratified refractive prediction error metrics among Chinese, Caucasian and other ethnic subgroups
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1 month postoperatively
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Incidence of transient ocular adverse events related to study biometric scans
時間枠：From the preoperative measurement until completion of the 1-month postoperative follow-up
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Proportion of participants with temporary dry eye, glare or foreign body sensation after repeated optical measurements
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From the preoperative measurement until completion of the 1-month postoperative follow-up
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協力者と研究者
捜査官
- 主任研究者：Mingguang He, Prof.、The Hong Kong Polytechnic University
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
- HK-WH-OPH-202607
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?
IPD プランの説明
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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