Validation of the Utility of Strabismus Intelligent Diagnostic System
1 other identifier
observational
323
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedJune 4, 2020
June 1, 2020
9 months
June 2, 2020
June 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of accurate, mistaken and miss detection of the diagnostic system.
up to 3 years
Study Arms (1)
Eligible patients for AI test
Device: strabismus diagnostic system.
Interventions
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.
Eligibility Criteria
A prospective study to validate the accuracy of the strabismus intelligent diagnostic system in the clinical practice.
You may qualify if:
- Patients in the outpatient clinic of strabismus department.
You may not qualify if:
- Patients or their parents diagree to participate in the trial.
- Patients with blepharoptosis.
- Patients can't facing forward or lacking fixation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 4, 2020
Study Start
September 1, 2019
Primary Completion
June 10, 2020
Study Completion
June 10, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06