A Big Data-based Cohort Study for Cataract Patients

Cataract Clinical Trial

Official title:

A Big Data-based Cohort Study for Cataract Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491798
• Other study ID #: CCPMOH2021-China-1
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: Haotian Lin, M.D., Ph.D.
• Phone: 8613802793086
• Email: linht5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Previous studies have found that the surgical complications and postoperative visual function of cataract patients are closely related to the condition of the fundus, but the current fundus camera cannot perform clear fundus imaging of cataract patients, and the existing potential visual inspections, such as retinal visual inspection, are also inaccurate. Predict postoperative visual acuity. Therefore, there is an urgent need for a reliable postoperative effect prediction system for cataract patients to provide reference for both ophthalmologists and patients.

This study intends to collect patient medical record information and traditional/ultra-wide fundus photos and other multi-modal data. Firstly, this study will use artificial intelligence technology to enhance fundus photos of cataract patients to obtain clearer fundus photos. Then this study will use both medical record information and traditional/ultra-wide fundus photographs to predict postoperative vision and visual function of cataract patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.

Exclusion Criteria:

• Unwilling or unable to receive fundus photography

Related Conditions & MeSH terms

• Cataract
• Retina Disorder
• Retinal Diseases

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of best corrected visual acuity	Change of best corrected visual acuity from baseline to 1 week after surgery	Baseline and 1 week after surgery
Primary	Accuracy for detection of retinal disorders	Accuracy for detection of retinal disorders using enhanced fundus images	1 week after surgery