Clinical trial NCT06616506: Artificial Intelligence for Highly Myopic Cataract
Official title: Artificial Intelligence for Highly Myopic Cataract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
High Myopia
Myopia
Automatic Judgement
Risk Reduction
Diagnoses Disease
Keywords: highly myopic cataract
artificial intelligence
cataract
big data
Lead sponsor: Shanghai High Myopia Study Group
Sponsor class: OTHER
Collaborators: name: Eye and ENT Hospital of Fudan University
First posted: 2024-09-27
Enrollment: 500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective Cohort Study

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract
timeFrame: 10 YEARS
measure: a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract
timeFrame: 8 years
Secondary outcomes:
measure: a multi-center artificial intelligence model for the risk prediction of perioperative complications and its clinical application in highly myopic cataract
timeFrame: 10 years
measure: a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: XIANGJIA ZHU
role: STUDY_CHAIR
References: