CataractNCT07733154
AI-Driven IOL Prediction Using SS-OCT Biometry
An observational study of Cataract, run by The Hong Kong Polytechnic University at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- IOLMaster 700 and Novel SS-OCT Biometer
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Aug 2026to 31 Mar 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification and posterior chamber IOL implantation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Australia1 site
Royal Adelaide Hospital (tentative)
Adelaide
Cheung Wong, 8613714543967, cheung.p.wong@gmail.com
China1 site
Wuhan Purui Ophthalmology Hospital
Wuhan, Hebei, 430032
zhimin Huang, 8615007176939, 625806284@qq.com
Hong Kong1 site
Hong Kong Eye Hospital
Kowloon City
Jijing Li, 85247412617, jijing0306@gmail.com
About this study
Official title: 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:
Read more
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
- Being tested
- IOLMaster 700, Novel SS-OCT Biometer
- Keywords
- Swept-source OCT, ocular biometry, intraocular lens power calculation, cataract surgery, axial length, IOLMaster comparison
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMaster 700Device
Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care.
Novel SS-OCT BiometerDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IOLMaster 700; Device: Novel SS-OCT Biometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperatively (single measurement visit before cataract surgery)
Secondary outcomes (4)
Measurement success rate of two biometers
Percentage of valid, analyzable scans obtained from Novel SS-OCT Biometer vs IOLMaster 700
Measured: 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
Measured: 1 month postoperatively
AI model performance across multi-ethnic cohorts
Stratified refractive prediction error metrics among Chinese, Caucasian and other ethnic subgroups
Measured: 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
Measured: From the preoperative measurement until completion of the 1-month postoperative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingguang He, Prof., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733154
- Sponsor's protocol ID
- HK-WH-OPH-202607
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Evaluation of a Novel SS-OCT Biometer and Development of an AI-Driven Intraocular Lens Power Prediction Model
- ClinicalTrials.gov ID
- NCT07733154
- Acronym / sponsor ID
- HK-WH-OPH-202607
- Conditions
- Cataract
- Keywords
- Swept-source OCT, ocular biometry, intraocular lens power calculation, cataract surgery, axial length, IOLMaster comparison
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgical Participants | – | Device: IOLMaster 700, Device: Novel SS-OCT BiometerAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification and posterior chamber IOL implantation.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOLMaster 700Commercially available swept-source OCT biometer for routine preoperative cataract ocular biometry, used for standard clinical care. | Device | Cataract Surgical Participants |
| Novel SS-OCT BiometerInvestigational 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. | Device | Cataract Surgical Participants |
Primary outcome
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
4 secondary outcomes
Measurement success rate of two biometers
Time frame: Preoperatively
Refractive prediction error of AI-driven IOL power model
Time frame: 1 month postoperatively
AI model performance across multi-ethnic cohorts
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingguang He, Prof. principal investigator
The Hong Kong Polytechnic University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by The Hong Kong Polytechnic University at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jijing Li (+85247412617, jijing0306@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.