Comparison of Artificial Intelligent Clinic and Normal Clinic

Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03240848

Enrollment

350

Registered

2017-08-07

Start date

2017-08-09

Completion date

2018-05-25

Last updated

2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

congenital cataract, artificial intelligent clinic

Brief summary

In this study, the investigators provide participants≤14 years old the artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.

Detailed description

Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to two groups: participants in group A went to the artificial intelligent clinic and get the initial diagnosis, while in Group B, the participants went to the normal clinic. Investigators provide the final definite diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis, time consuming and the satisfaction level between two groups, aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.

Interventions

PROCEDUREartificial intelligent clinic

Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.

PROCEDUREnormal clinic

Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.

PROCEDUREexperts diagnose

After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

Slit-lamp photography and patient recruitment will be performed in each participating clinic by trained clinical staffs. The clinical staffs, investigators involved in data management and analysis, and experts providing the gold standard diagnosis by consensus in each clinic will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.

Eligibility

Sex/Gender

ALL

Age

1 Months to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* Paediatric patients from collaborating eye clinics Written informed consents provided

Exclusion criteria

* Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery Can not cooperate with the slip lamp examination Unwilling to participate in this trail

Design outcomes

Primary

Measure	Time frame	Description
The accuracy of artificial intelligence diagnosis for congenital cataract	baseline	The accuracy of artificial intelligence diagnosis was calculated.

Secondary

Measure	Time frame	Description
The evaluation of disease severity and treatment determination	baseline	The accuracy of the evaluation of disease severity and treatment determination was calculated
The time consuming of diagnosis	baseline	The time consuming of diagnosis was calculated.
The level of patients' satisfaction	baseline	The information about patients' satisfaction was recorded by using a questionnaire.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026