NCT04138771

Brief Summary

Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

7.2 years

First QC Date

October 23, 2019

Last Update Submit

December 1, 2019

Conditions

CataractPostoperative ComplicationsArtificial Intelligence

Keywords

Conjunctival hyperemiaPterygiumIntraocular lens dislocationPosterior capsule opacificationPupil malformationSuppurative endophthalmitis

Outcome Measures

Primary Outcomes (1)

  • The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.

    Up to 7 years

Study Arms (1)

Eligible patients for AI test

EXPERIMENTAL

Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center.

Device: An artificial intelligence system for postoperative management of cataract patients

Interventions

An artificial intelligence system for postoperative management of cataract patientsDEVICE

This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.

Eligible patients for AI test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had surgery of cataract extraction combined with introcular lens implantation.
  • Patients should be aware of the contents and signed for the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

CataractPostoperative ComplicationsPterygiumPupil Disorders

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsConjunctival DiseasesNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 24, 2019

Study Start

January 1, 2013

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

December 3, 2019

Record last verified: 2019-12

Locations

CN(1)