NCT05204095

Brief Summary

Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

January 10, 2022

Last Update Submit

January 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The accuracy of referral

    The accuracy of referral of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.

    Baseline

Secondary Outcomes (1)

  • The accuracy of cataract diagnosis

    Baseline

Study Arms (2)

Referral group

The patients with severe cataracts in this group need a referral to a higher-level hospital for further treatment.

Device: Portable slit-lamp photography

Observation group

The patients with mild cataracts or transparent lenses in this group do not need a referral to a higher-level hospital for further treatment and keep regular examinations.

Device: Portable slit-lamp photography

Interventions

The enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison.

Observation groupReferral group

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The prospective population aged 0 to 100 with or without senile cataracts and received ocular examination.

You may qualify if:

  • to 100 years old

You may not qualify if:

  • (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510060, China

Location

Study Officials

  • Yizhi Liu, M.D., Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

    STUDY CHAIR

Central Study Contacts

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

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

February 10, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations