Usability User Testing of the Easy-EyeFM AI Platform

Easy-EyeFM is a code-free artificial intelligence platform designed for ophthalmologists to provide diagnostic and treatment recommendations and help doctors develop customized diagnostic models.

This project aims to evaluate the usability and user-friendliness of the Easy-EyeFM platform for physicians. The study will gather feedback from medical professionals to evaluate the intuitiveness and effectiveness of the platform in supporting model customization and medical image analysis tasks.

Subjects will participate in the trial of the Easy-EyeFM platform and the comparison with the existing commercial platform (AutoML) at the appointed time. The researchers will inform subjects of relevant precautions and assist them to read the user manual before the test. Subjects will complete model customization and picture diagnosis within the prescribed test time, and according to the test results, Score the human-computer interaction experience of the AI platform, fill in the questionnaire, and finally complete the evaluation content.

Study Overview

• Status: Recruiting
• Conditions: Ocular Diseases
• Intervention / Treatment: Diagnostic test: EasyEyeFM-AutoML-AI-platform test; Diagnostic test: AutoML-EasyEyeFM-AI-platform test

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinyuan Wang; Phone Number: 086-15801191316; Email: jinyuanwang@tsinghua.edu.cn
• Study Contact Backup: Name: Hongqiu Wang; Email: hwang007@connect.hkust-gz.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Tsinghua University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Medical students or doctors
• Have enough time to participate in this program, about 1 hour continuous assessment
• Agree to sign the informed consent form

Exclusion Criteria:

• Poor computer and mobile phone use and reading ability
• Poor language expression or dialect category is not included in the speech recognition function of the platform

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A	Diagnostic test: EasyEyeFM-AutoML-AI-platform test; AI platforms using
Experimental: group B	Diagnostic test: AutoML-EasyEyeFM-AI-platform test; AI-platform using

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome, meaning higher system usability.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Usage Time	1 day
Users Assistance Requests Times	1 day

Collaborators and Investigators

• Sponsor: Tsinghua University
• Collaborators: Moorfields Eye Hospital NHS Foundation Trust; Royal Victoria Eye and Ear Hospital; Korle-Bu Teaching Hospital, Accra, Ghana; Beijing Tsinghua Changgeng Hospital; First Hospital of Tsinghua University; Hong Kong Eye Hospital; Hanyang University Guri Hospitall; Shanghai Health and Medical Center; Augenarzt-Praxisgemeinschaft Gutblick AG; Sankara Nethralaya; Department of Medical Services Ministry of Public Health of Thailand; Pomeranian Hospitals; Alshifa Trust Eye Hospital; Nippon Medical School Tama Nagayama Hospital
• Investigators: Principal Investigator: Tien Yin Wong, Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Easy-EyeFM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No