Artificial Intelligence for Highly Myopic Cataract

NCT ID: NCT06616506

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2035-12-31

Brief Summary

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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

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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

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Cataract High Myopia Myopia Automatic Judgement Risk Reduction Diagnoses Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Highly myopic cataract patients without fundus defects

Highly myopic cataract patients with fundus defects

newly-invented AI model

Intervention Type DEVICE

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

Highly myopic cataract patients with fundus defects

newly-invented AI model

Intervention Type DEVICE

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

Highly myopic cataract patients with lens grading of NC2-3

newly-invented AI model

Intervention Type DEVICE

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

Highly myopic cataract patients with lens grading of NC4-5

newly-invented AI model

Intervention Type DEVICE

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

Interventions

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newly-invented AI model

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye and ENT Hospital of Fudan University

UNKNOWN

Sponsor Role collaborator

Shanghai High Myopia Study Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XIANGJIA ZHU

Role: STUDY_CHAIR

Eye & ENT Hospital of Fudan University

Locations

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Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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WENWEN HE

Role: CONTACT

+86-15021154594

KEKE ZHANG

Role: CONTACT

Facility Contacts

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XIANGJIA ZHU, M.D.

Role: primary

(86)021-64377134

Other Identifiers

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SYA202006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SHDC12019X08

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NSFC-81970780

Identifier Type: -

Identifier Source: org_study_id