AI-Driven IOL Prediction Using SS-OCT Biometry

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07733154
Status
Not Yet Recruiting

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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Aug 20, 2026
Status verified
Jul 2026
Primary completion
Mar 20, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

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