Validation of the Utility of Strabismus Intelligent Diagnostic System

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

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.

Study Overview

• Status: Unknown
• Conditions: Strabismus; Ophthalmological Disorder
• Intervention / Treatment: Drug: Strabismus diagnostic system.

• Study Type: Observational
• Enrollment (Anticipated): 323

Contacts and Locations

• Study Contact: Name: Keli Mao, M.D; Phone Number: 87330493; Email: maokl@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Keli Mao, M.D.; Phone Number: 87330493; Email: maokl@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eligible patients for AI test; Device: strabismus diagnostic system.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): June 10, 2020
• Study Completion (Anticipated): June 10, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Eye Diseases; Strabismus
• Other Study ID Numbers: SIDS-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No