The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial

Artificial Intelligence Clinical Trial

— AI  

Official title:

The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919837
• Other study ID #: SFLVRCT-2020
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.

Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 105 Years

Eligibility

Inclusion Criteria:

• Low vision Aged 3 to 105

Exclusion Criteria:

• Severe systemic diseases Failure to sign informed consent or unwilling to participate

Related Conditions & MeSH terms

• Artificial Intelligence
• Low Vision Aids
• Ophthalmology
• Vision, Low

Intervention

Other:
• Low vision aids
the assisting devices fitting for low-vision patients

Locations

Country	Name	City	State
China	2nd Affilliated Hospital of Jujian Medical University	Quanzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	2nd Affilliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of giving up assisting devices	The investigator will calculate the proportion of giving up more than one assisting devices in two groups for three months and six months	Baseline
Secondary	Time cost of using assisting devices of patients	The investigator will apply survival analysis for the time cost of using assisting devices in different groups.	Baseline