Validation of the Utility of Strabismus Intelligent Diagnostic System

NCT ID: NCT04416776

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

323 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-06-10

Brief Summary

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Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.

Detailed Description

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Conditions

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Ophthalmological Disorder Strabismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eligible patients for AI test

Device: strabismus diagnostic system.

Strabismus diagnostic system.

Intervention Type DRUG

An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning.

Interventions

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Strabismus diagnostic system.

An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients in the outpatient clinic of strabismus department.

Exclusion Criteria

* Patients or their parents diagree to participate in the trial.
* Patients with blepharoptosis.
* Patients can't facing forward or lacking fixation.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Keli Mao, M.D

Role: CONTACT

Facility Contacts

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Keli Mao, M.D.

Role: primary

Other Identifiers

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SIDS-2020

Identifier Type: -

Identifier Source: org_study_id

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