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NCT Number: NCT06616506

Artificial Intelligence for Highly Myopic Cataract

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

XIANGJIA ZHU, M.D.

CONTACT

[email protected]

(86)021-64377134

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

newly-invented AI model

Device

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

KEKE ZHANG

CONTACT

[email protected]

WENWEN HE

CONTACT

[email protected]

+86-15021154594

Sponsors and collaborators

Lead sponsor

Shanghai High Myopia Study Group

Other

Collaborators

  • Eye and ENT Hospital of Fudan University

Registry information

Acronym: AI-HMC

Important dates

Study start
2016
Primary completion
2030
Study completion
2035
First posted
Sep 27, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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