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RecruitingNCT06616506AI-HMCUpdated May 11, 2026

Artificial Intelligence for Highly Myopic Cataract

An observational study in Cataract, High Myopia and Myopia, sponsored by Shanghai High Myopia Study Group. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Shanghai High Myopia Study Group · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500,000
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cataract
  • High Myopia
  • Myopia
  • Automatic Judgement
  • Risk Reduction
  • Diagnoses Disease

Keywords

  • highly myopic cataract
  • artificial intelligence
  • cataract
  • big data
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 500,000 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Shanghai High Myopia Study Group is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

Prospective Cohort Study

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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

Patients who are unable to cooperate with the required examinations for this study.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Highly myopic cataract patients without fundus defects

    Highly myopic cataract patients with fundus defects

    Device: newly-invented AI model

  • 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

Interventions

  • Devicenewly-invented AI model

    Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.

06

What researchers measure

Primary outcomes

  1. 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

  2. a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract

    Time frame: 8 years

Secondary outcomes

  1. 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

  2. a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for Dec 2030, 179 months after the start.

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 179 months is above 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.

Registered
Sep 25, 2024
First posted
Sep 27, 2024
StartActual
Jan 1, 2016
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2035
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06616506
Lead sponsor
Shanghai High Myopia Study Group
Collaborators
Eye and ENT Hospital of Fudan University
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Jan 1, 2016
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
May 11, 2026

Study contacts

WENWEN HE
Contact
alicewen@139.com
+86-15021154594
KEKE ZHANG
Contact
shirley18158@163.com
XIANGJIA ZHU
study chair · Eye & ENT Hospital of Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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