NCT04314180

Brief Summary

Slit-lamp images are widely used in ophthalmology for the detection of cataract, keratopathy and other anterior segment disorders. In real-world practice, the quality of slit-lamp images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of slit-lamp images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.

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 all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 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

February 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 16, 2020

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance of artificial intelligence system for distinguish between good image quality and poor image quality

    Area under the receiver operating characteristic curves, sensitivity, specificity, positive and negative predictive values,accuracy

    3 months

Secondary Outcomes (1)

  • The comparison of the performance for previous artificial intelligence diagnostic system with slit-lamp images of different image quality

    3 months

Study Arms (1)

Slit-lamp image quality assessment

Device: an artificial intelligence system for quality assessment of slit-lamp images. These patients are enrolled in primary healthcare units or the AI clinic at Zhongshan Ophthalmic Center

Device: Taking slit-lamp images

Interventions

The participant only needs to take several slit-lamp images as usual.

Slit-lamp image quality assessment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: - Patients should be aware of the contents and signed for the informed consent. Exclusion Criteria: - 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths. - 2. Patients who do not agree to sign informed consent

You may qualify if:

  • Patients should be aware of the contents and signed for the informed consent.

You may not qualify if:

  • \. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
  • \. Patients who do not agree to sign 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

Location

Study Design

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

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 19, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations