- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06616506
Artificial Intelligence for Highly Myopic Cataract (AI-HMC)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: KEKE ZHANG
- Email: shirley18158@163.com
Study Contact Backup
- Name: WENWEN HE
- Phone Number: +86-15021154594
- Email: alicewen@139.com
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200031
- Recruiting
- Eye and ENT Hospital of Fudan University
-
Contact:
- XIANGJIA ZHU, M.D.
- Phone Number: (86)021-64377134
- Email: zhuxiangjia1982@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Study Chair: XIANGJIA ZHU, Eye & ENT Hospital of Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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