An observational study in Cataract, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by The Hong Kong Polytechnic University · Observational
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification and posterior chamber IOL implantation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
Time frame: Preoperatively (single measurement visit before cataract surgery)
Measurement success rate of two biometers
Percentage of valid, analyzable scans obtained from Novel SS-OCT Biometer vs IOLMaster 700
Time frame: Preoperatively
Refractive prediction error of AI-driven IOL power model
Mean absolute error (MAE), median absolute error (MedAE), root mean square error (RMSE); proportion of eyes within ±0.5D / ±1.0D refractive prediction error
Time frame: 1 month postoperatively
AI model performance across multi-ethnic cohorts
Stratified refractive prediction error metrics among Chinese, Caucasian and other ethnic subgroups
Time frame: 1 month postoperatively
Incidence of transient ocular adverse events related to study biometric scans
Proportion of participants with temporary dry eye, glare or foreign body sensation after repeated optical measurements
Time frame: From the preoperative measurement until completion of the 1-month postoperative follow-up
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Mar 2027, 7 months later.
Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 7 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Hong Kong Polytechnic University →