International Multicenter Evaluation of a Novel SS-OCT Biometer and Development of an AI-Driven Intraocular Lens Power Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700
时间窗: 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
次要结局
- Measurement success rate of two biometers(Preoperatively)
- Refractive prediction error of AI-driven IOL power model(1 month postoperatively)
- AI model performance across multi-ethnic cohorts(1 month postoperatively)
- Incidence of transient ocular adverse events related to study biometric scans(From the preoperative measurement until completion of the 1-month postoperative follow-up)