AI-Driven IOL Prediction Using SS-OCT Biometry

July 23, 2026 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital (tentative)
        • Contact:
  • China
    • Hebei
      • Wuhan, Hebei, China, 430032
        • Wuhan Purui Ophthalmology Hospital
        • Contact:
  • Hong Kong
      • Kowloon City, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Aged 18 years or above.
  2. Diagnosed with age-related cataract.
  3. Scheduled for routine phacoemulsification with posterior chamber intraocular lens implantation.
  4. Able to cooperate with preoperative ocular biometric measurements and postoperative assessments.
  5. Able to attend the planned 1-month postoperative follow-up visit.
  6. Able to understand the study information and provide written informed consent.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Cognitive impairment, severe mental disorder, or other condition that prevents the participant from understanding the study or providing valid informed consent.
  5. Poor cooperation that prevents reliable ocular biometric measurement or follow-up assessment.
  6. Current participation in another interventional clinical study that may affect the outcomes of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement success rate of two biometers
Time Frame: Preoperatively
Percentage of valid, analyzable scans obtained from Novel SS-OCT Biometer vs IOLMaster 700
Preoperatively
Refractive prediction error of AI-driven IOL power model
Time Frame: 1 month postoperatively
Mean absolute error (MAE), median absolute error (MedAE), root mean square error (RMSE); proportion of eyes within ±0.5D / ±1.0D refractive prediction error
1 month postoperatively
AI model performance across multi-ethnic cohorts
Time Frame: 1 month postoperatively
Stratified refractive prediction error metrics among Chinese, Caucasian and other ethnic subgroups
1 month postoperatively
Incidence of transient ocular adverse events related to study biometric scans
Time Frame: From the preoperative measurement until completion of the 1-month postoperative follow-up
Proportion of participants with temporary dry eye, glare or foreign body sensation after repeated optical measurements
From the preoperative measurement until completion of the 1-month postoperative follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Mingguang He, Prof., The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK-WH-OPH-202607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

External sharing of individual participant data (IPD) is not planned. The raw ophthalmic imaging and clinical records are solely reserved for internal AI model training and analysis by the official multi-country research consortium. Participant informed consent does not authorize release of personal-level data to external researchers, and cross-border privacy laws as well as institutional IRB requirements restrict cross-site data distribution to third parties. In addition, the dataset carries proprietary intellectual property for AI medical device development, and external data access may cause unauthorized duplication of core algorithms.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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