Intelligent Cataract Screening With Portable Slit-lamp (AI)

January 10, 2022 updated by: Haotian Lin, Sun Yat-sen University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haotian Lin, M.D., Ph.D.
  • Phone Number: +86-020-87330274
  • Email: gddlht@aliyun.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 0 to 100 years old

Exclusion Criteria:

  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison.
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
The enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of referral
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of cataract diagnosis
Time Frame: Baseline
The accuracy of cataract diagnosis of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Yizhi Liu, M.D., Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 10, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLCS-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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