AI-Driven IOL Prediction Using SS-OCT Biometry

Официальное название

International Multicenter Evaluation of a Novel SS-OCT Biometer and Development of an AI-Driven Intraocular Lens Power Prediction Model

Обзор

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.

Вмешательства

• Устройство IOLMaster 700
  Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care.
• Устройство 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.

Первичные конечные точки

• Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700 [Срок оценки: Preoperatively (single measurement visit before cataract surgery)]

Вторичные конечные точки (4)

• Measurement success rate of two biometers [Срок оценки: Preoperatively]
• Refractive prediction error of AI-driven IOL power model [Срок оценки: 1 month postoperatively]
• AI model performance across multi-ethnic cohorts [Срок оценки: 1 month postoperatively]
• Incidence of transient ocular adverse events related to study biometric scans [Срок оценки: From the preoperative measurement until completion of the 1-month postoperative follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австралия · 1 центр

• Royal Adelaide Hospital (tentative) — Adelaide

Китай · 1 центр

• Wuhan Purui Ophthalmology Hospital — Ухань

Гонконг · 1 центр

• Hong Kong Eye Hospital — Kowloon City

Идентификаторы

NCT: NCT07733154 · HK-WH-OPH-202607

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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