A Big Data-based Cohort Study for Cataract Patients

Recruiting

• Conditions: Cataract; Retina Disorder

• Registration Number: NCT05491798
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-08-07
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Unwilling or unable to receive fundus photography

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of best corrected visual acuity	Baseline and 1 week after surgery	Change of best corrected visual acuity from baseline to 1 week after surgery
Accuracy for detection of retinal disorders	1 week after surgery	Accuracy for detection of retinal disorders using enhanced fundus images

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China