Artificial Intelligence for Highly Myopic Cataract (AI-HMC)

May 6, 2026 updated by: Shanghai High Myopia Study Group
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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

500000

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 Contact Backup

Study Locations

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Prospective Cohort Study

Description

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:

Patients who are unable to cooperate with the required examinations for 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
Highly myopic cataract patients without fundus defects
Highly myopic cataract patients with fundus defects
Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.
Highly myopic cataract patients with fundus defects
Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.
Highly myopic cataract patients with lens grading of NC2-3
Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.
Highly myopic cataract patients with lens grading of NC4-5
Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 YEARS
a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract
Time Frame: 8 years
8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
10 years

Collaborators and Investigators

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

Investigators

  • Study Chair: XIANGJIA ZHU, Eye & ENT Hospital of Fudan 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 (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NSFC-81970780
  • SYA202006 (Other Grant/Funding Number: Eye and Ear, Nose and Throat Hospital, Fudan University)
  • SHDC12019X08 (Other Grant/Funding Number: Shanghai Shenkang Hospital Development Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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