CataractAI-HMCNCT06616506
Artificial Intelligence for Highly Myopic Cataract
An observational study of Cataract and High Myopia, run by Shanghai High Myopia Study Group at 1 site in China.
Trial summary
This study aims to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract, High Myopia, Myopia
- What is being tested?
- newly-invented AI model
- Type of treatment
- Medical device
- How many people
- 500,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2035
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Prospective Cohort Study
Who may be able to join
- Axial length ≥ 26 mm and patients with high myopia complicated by cataracts who visit our hospital.
- Preoperative anterior segment photography and cataract severity assessment, along with fundus OCT examination, have been performed.
- If surgical treatment is conducted, the postoperative follow-up period should be no less than 1 month.
- There are no missing clinical data before and after the surgery.
Who cannot join
- Patients who are unable to cooperate with the required examinations for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
KEKE ZHANG contact
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
XIANGJIA ZHU, M.D., (86)021-64377134, zhuxiangjia1982@126.com
About this study
This study aims to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.
Read the detailed description
High myopia cataract (HMC) is a complex cataract with high risk of blindness. At present, there are nearly 300 million people with high myopia in the world, which will increase to 500 million by 2020. Asia is the high incidence of myopia in the world. At present, there are more than 500 million people with myopia in China alone, of which nearly 100 million are high myopia, and this number is still growing rapidly. Correspondingly, the incidence rate of cataract with high myopia has also increased rapidly, which accounts for over 40% of cataract surgery.
In the early stage of the project team's analysis of refractive error after high myopia cataract surgery, it was found that the accuracy of intraocular lens calculation formula, which is widely recommended for high myopia cataract at present, is still worrying, because most of these formulas are based on the European and American eye data, while the European and American databases have few ultra high myopia data, which greatly affects the formula's accuracy In addition, the calculation of the existing formula needs to include multiple biometric indicators, and can be obtained based on complex algorithms. Artificial intelligence technology is exactly an effective means to solve this kind of problem. Therefore, based on the data of Asian population with high myopia and high incidence, the establishment of an intelligent model for the accurate calculation of high myopia cataract IOL will greatly improve the measurement accuracy Sex.
Therefore, the purpose of this study is to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.
- Conditions
- Cataract, High Myopia, Myopia, Automatic Judgement, Risk Reduction, Diagnoses Disease
- Being tested
- newly-invented AI model
- Keywords
- highly myopic cataract, artificial intelligence, cataract, big data
- Medical subject headings
- Cataract, Myopia, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
newly-invented AI modelDevice
Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.
| Study group | Role | What they receive |
|---|---|---|
| Highly myopic cataract patients without fundus defects | Highly myopic cataract patients with fundus defects Receives: Device: newly-invented AI model | |
| Highly myopic cataract patients with fundus defects | Not described Receives: Device: newly-invented AI model | |
| Highly myopic cataract patients with lens grading of NC2-3 | Not described Receives: Device: newly-invented AI model | |
| Highly myopic cataract patients with lens grading of NC4-5 | Not described Receives: Device: newly-invented AI model |
What is being measured
The primary outcome is the main question the study is designed to answer.
a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract
Measured: 10 YEARS
a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract
Measured: 8 years
Secondary outcomes (2)
a multi-center artificial intelligence model for the risk prediction of perioperative complications and its clinical application in highly myopic cataract
Measured: 10 years
a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (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
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai High Myopia Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- XIANGJIA ZHU, Study chair, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616506
- Sponsor's protocol ID
- NSFC-81970780
- Other IDs
- SYA202006, SHDC12019X08
- Acronym
- AI-HMC
- Status last verified
- May 2026
- First submitted
- 25 Sep 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Highly Myopic Cataract
- ClinicalTrials.gov ID
- NCT06616506
- Acronym / sponsor ID
- AI-HMC / NSFC-81970780
- Conditions
- Cataract, High Myopia, Myopia, Automatic Judgement, Risk Reduction, Diagnoses Disease
- Keywords
- highly myopic cataract, artificial intelligence, cataract, big data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Shanghai High Myopia Study GroupUniversity, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 27 Sep 2024 (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 study aims to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.
Detailed description
High myopia cataract (HMC) is a complex cataract with high risk of blindness. At present, there are nearly 300 million people with high myopia in the world, which will increase to 500 million by 2020. Asia is the high incidence of myopia in the world. At present, there are more than 500 million people with myopia in China alone, of which nearly 100 million are high myopia, and this number is still growing rapidly. Correspondingly, the incidence rate of cataract with high myopia has also increased rapidly, which accounts for over 40% of cataract surgery.
In the early stage of the project team's analysis of refractive error after high myopia cataract surgery, it was found that the accuracy of intraocular lens calculation formula, which is widely recommended for high myopia cataract at present, is still worrying, because most of these formulas are based on the European and American eye data, while the European and American databases have few ultra high myopia data, which greatly affects the formula's accuracy In addition, the calculation of the existing formula needs to include multiple biometric indicators, and can be obtained based on complex algorithms. Artificial intelligence technology is exactly an effective means to solve this kind of problem. Therefore, based on the data of Asian population with high myopia and high incidence, the establishment of an intelligent model for the accurate calculation of high myopia cataract IOL will greatly improve the measurement accuracy Sex.
Therefore, the purpose of this study is to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Highly myopic cataract patients without fundus defects | – | Device: newly-invented AI modelHighly myopic cataract patients with fundus defects |
| Highly myopic cataract patients with fundus defects | – | Device: newly-invented AI model |
| Highly myopic cataract patients with lens grading of NC2-3 | – | Device: newly-invented AI model |
| Highly myopic cataract patients with lens grading of NC4-5 | – | Device: newly-invented AI model |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective Cohort Study
Key inclusion criteria (4 listed)
- Axial length ≥ 26 mm and patients with high myopia complicated by cataracts who visit our hospital.
- Preoperative anterior segment photography and cataract severity assessment, along with fundus OCT examination, have been performed.
- If surgical treatment is conducted, the postoperative follow-up period should be no less than 1 month.
- There are no missing clinical data before and after the surgery.
Key exclusion criteria (1 listed)
- Patients who are unable to cooperate with the required examinations for this study.
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 |
|---|---|---|
| newly-invented AI modelApply newly-invented AI models to assist in determining surgical plans and outcome prediction. | Device | Highly myopic cataract patients with fundus defects, Highly myopic cataract patients with lens grading of NC2-3, Highly myopic cataract patients with lens grading of NC4-5, Highly myopic cataract patients without fundus defects |
Primary outcome
a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract
Time frame: 10 YEARS
a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract
Time frame: 8 years
2 secondary outcomes
a multi-center artificial intelligence model for the risk prediction of perioperative complications and its clinical application in highly myopic cataract
Time frame: 10 years
a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract
Time frame: 10 years
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
KEKE ZHANG contact
XIANGJIA ZHU study chair
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and High Myopia, run by Shanghai High Myopia Study Group at 1 site in China.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 WENWEN HE (+86-15021154594, alicewen@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract (time frame: 10 YEARS). The study lists 2 primary outcomes in all. 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 11 May 2026.