Artificial Intelligence for Highly Myopic Cataract

NCT06616506 | Recruiting DMC

• 3 other identifiers: NSFC-81970780SYA202006SHDC12019X08
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; High Myopia; Myopia; Automatic Judgement; Risk Reduction; Diagnoses Disease

Keywords

highly myopic cataract; artificial intelligence; cataract; big data

Outcome Measures

Primary Outcomes (2)

• a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract

  10 YEARS

• a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract

  8 years

Secondary Outcomes (2)

• a multi-center artificial intelligence model for the risk prediction of perioperative complications and its clinical application in highly myopic cataract

  10 years

• a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract

  10 years

Study Arms (4)

Highly myopic cataract patients without fundus defects

Highly myopic cataract patients with fundus defects

Device: newly-invented AI model

Highly myopic cataract patients with fundus defects

Device: newly-invented AI model

Highly myopic cataract patients with lens grading of NC2-3

Device: newly-invented AI model

Highly myopic cataract patients with lens grading of NC4-5

Device: newly-invented AI model

Interventions

newly-invented AI model DEVICE

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

Highly myopic cataract patients with fundus defects; Highly myopic cataract patients with lens grading of NC2-3; Highly myopic cataract patients with lens grading of NC4-5; Highly myopic cataract patients without fundus defects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective Cohort Study

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unable to cooperate with the required examinations for this study.

Sponsors & Collaborators

• Shanghai High Myopia Study Group: lead
• Eye and ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Cataract; Myopia; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors; Behavior

Study Officials

• XIANGJIA ZHU

  Eye & ENT Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

WENWEN HE

CONTACT

+86-15021154594; alicewen@139.com

KEKE ZHANG

CONTACT

shirley18158@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CN (1)