AI-Driven IOL Prediction Using SS-OCT Biometry

NCT07733154 | Not Yet Recruiting

• 1 other identifier: HK-WH-OPH-202607
• Study Type: observational
• Target: 2,500
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Cataract

Keywords

Swept-source OCT; ocular biometry; intraocular lens power calculation; cataract surgery; axial length; IOLMaster comparison

Outcome Measures

Primary Outcomes (1)

• Agreement of ocular biometric parameters between Novel SS-OCT Biometer and IOLMaster 700

  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)

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Device: IOLMaster 700; Device: Novel SS-OCT Biometer

Interventions

IOLMaster 700 DEVICE

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

Cataract Surgical Participants

Novel SS-OCT Biometer DEVICE

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.

Cataract Surgical Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (3)

Royal Adelaide Hospital (tentative)

Adelaide, Australia

Location

Wuhan Purui Ophthalmology Hospital

Wuhan, Hebei, 430032, China

Location

Hong Kong Eye Hospital

Kowloon City, Hong Kong

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Mingguang He, Prof.

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijing Li

CONTACT

+85247412617; jijing0306@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); HK (1); CN (1)