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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jijing Li
- 전화번호: +85247412617
- 이메일: jijing0306@gmail.com
연구 장소
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Hebei
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Wuhan, Hebei, 중국, 430032
- Wuhan Purui Ophthalmology Hospital
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연락하다:
- zhimin Huang
- 전화번호: 8615007176939
- 이메일: 625806284@qq.com
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Adelaide, 호주
- Royal Adelaide Hospital (tentative)
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연락하다:
- Cheung Wong
- 전화번호: 8613714543967
- 이메일: cheung.p.wong@gmail.com
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Kowloon City, 홍콩
- Hong Kong Eye Hospital
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연락하다:
- Jijing Li
- 전화번호: 85247412617
- 이메일: jijing0306@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Measurement success rate of two biometers
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Mingguang He, Prof., The Hong Kong Polytechnic University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HK-WH-OPH-202607
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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