此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

AI-Driven IOL Prediction Using SS-OCT Biometry

2026年7月23日 更新者：The Hong Kong Polytechnic University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

2500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Hebei
      • Wuhan、Hebei、中国、430032
        • Wuhan Purui Ophthalmology Hospital
        • 接触：
  • 澳大利亚
      • Adelaide、澳大利亚
        • Royal Adelaide Hospital (tentative)
        • 接触：
  • 香港
      • Kowloon City、香港
        • Hong Kong Eye Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification and posterior chamber IOL implantation.

描述

Inclusion Criteria:

  1. Aged 18 years or above.
  2. Diagnosed with age-related cataract.
  3. Scheduled for routine phacoemulsification with posterior chamber intraocular lens implantation.
  4. Able to cooperate with preoperative ocular biometric measurements and postoperative assessments.
  5. Able to attend the planned 1-month postoperative follow-up visit.
  6. Able to understand the study information and provide written informed consent.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Cognitive impairment, severe mental disorder, or other condition that prevents the participant from understanding the study or providing valid informed consent.
  5. Poor cooperation that prevents reliable ocular biometric measurement or follow-up assessment.
  6. Current participation in another interventional clinical study that may affect the outcomes of this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
设备：IOLMaster 700
Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care.
设备：Novel SS-OCT Biometer
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700
大体时间：Preoperatively (single measurement visit before cataract surgery)
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
Preoperatively (single measurement visit before cataract surgery)

次要结果测量

结果测量
措施说明
大体时间
Measurement success rate of two biometers
大体时间：Preoperatively
Percentage of valid, analyzable scans obtained from Novel SS-OCT Biometer vs IOLMaster 700
Preoperatively
Refractive prediction error of AI-driven IOL power model
大体时间：1 month postoperatively
Mean absolute error (MAE), median absolute error (MedAE), root mean square error (RMSE); proportion of eyes within ±0.5D / ±1.0D refractive prediction error
1 month postoperatively
AI model performance across multi-ethnic cohorts
大体时间：1 month postoperatively
Stratified refractive prediction error metrics among Chinese, Caucasian and other ethnic subgroups
1 month postoperatively
Incidence of transient ocular adverse events related to study biometric scans
大体时间：From the preoperative measurement until completion of the 1-month postoperative follow-up
Proportion of participants with temporary dry eye, glare or foreign body sensation after repeated optical measurements
From the preoperative measurement until completion of the 1-month postoperative follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Hong Kong Polytechnic University

调查人员

  • 首席研究员：Mingguang He, Prof.、The Hong Kong Polytechnic University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月20日

初级完成 (估计的)

2027年3月20日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HK-WH-OPH-202607

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

External sharing of individual participant data (IPD) is not planned. The raw ophthalmic imaging and clinical records are solely reserved for internal AI model training and analysis by the official multi-country research consortium. Participant informed consent does not authorize release of personal-level data to external researchers, and cross-border privacy laws as well as institutional IRB requirements restrict cross-site data distribution to third parties. In addition, the dataset carries proprietary intellectual property for AI medical device development, and external data access may cause unauthorized duplication of core algorithms.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅