NCT05491798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4.4 years

First QC Date

August 7, 2021

Last Update Submit

January 3, 2024

Conditions

Keywords

CataractPostoperative predictionImage enhancementRetina disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • Accuracy for detection of retinal disorders

    Accuracy for detection of retinal disorders using enhanced fundus images

    1 week after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.

You may qualify if:

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

You may not qualify if:

  • Unwilling or unable to receive fundus photography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • Liu L, Hong J, Wu Y, Liu S, Wang K, Li M, Zhao L, Liu Z, Li L, Cui T, Tsui CK, Xu F, Hu W, Yun D, Chen X, Shang Y, Bi S, Wei X, Lai Y, Lin D, Fu Z, Deng Y, Cai K, Xie Y, Cao Z, Wang D, Zhang X, Dongye M, Lin H, Wu X. Digital ray: enhancing cataractous fundus images using style transfer generative adversarial networks to improve retinopathy detection. Br J Ophthalmol. 2024 Sep 20;108(10):1423-1429. doi: 10.1136/bjo-2024-325403.

MeSH Terms

Conditions

CataractRetinal Diseases

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Haotian Lin, M.D., Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haotian Lin, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 8, 2022

Study Start

July 1, 2020

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations