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NCT04416776 Clinical Trial

Validation of the Utility of Strabismus Intelligent Diagnostic System

Strabismus Clinical Trial

Official title:
Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04416776
Other study ID # SIDS-2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date June 10, 2020

Study information
Verified date June 2020
Source Sun Yat-sen University
Contact Keli Mao, M.D
Phone 87330493
Email maokl@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 323
Est. completion date June 10, 2020
Est. primary completion date June 10, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of accurate, mistaken and miss detection of the diagnostic system. up to 3 years
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