Validation of the Utility of Strabismus Intelligent Diagn... | NCT04416776

Studies
Validation of the Utility of Strabismus Intelligent Diagnostic System

NCT04416776

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jun 4, 2020Actual

Enrollment

323Estimated

Phase

Not provided

Conditions

Ophthalmological Disorder
Strabismus

Interventions

Strabismus diagnostic system.

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Jun 10, 2020Estimated

Completion Date

Jun 10, 2020Estimated

First Submitted Date

Jun 2, 2020

First Submission Date that Met QC Criteria

Jun 2, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

323Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eligible patients for AI test		Device: strabismus diagnostic system.	Drug: Strabismus diagnostic system.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strabismus diagnostic system.	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of accurate, mistaken and miss detection of the diagnostic system.		up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

A prospective study to validate the accuracy of the strabismus intelligent diagnostic system in the clinical practice.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keli Mao, M.D	Contact	87330493		maokl@mail2.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases
D013285	Strabismus

Ancestor Terms

ID	Term
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided