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

NCT ID: NCT04919837

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ophthalmology Low Vision Aids Artificial Intelligence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Algorithm assisted group

Patients receive assisting devices fitting services from human doctors assisted by the machine learning model

Group Type EXPERIMENTAL

Low vision aids

Intervention Type OTHER

the assisting devices fitting for low-vision patients

Human doctor group

Patients receive assisting devices fitting services from humanr doctors

Group Type EXPERIMENTAL

Low vision aids

Intervention Type OTHER

the assisting devices fitting for low-vision patients

Interventions

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Low vision aids

the assisting devices fitting for low-vision patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Low vision Aged 3 to 105

Exclusion Criteria

* Severe systemic diseases Failure to sign informed consent or unwilling to participate
Minimum Eligible Age

3 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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2nd Affilliated Hospital of Fujian Medical University

UNKNOWN

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Affilliated Hospital of Jujian Medical University

Quanzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jianmin Hu, M.D., Ph.D.

Role: primary

+8615359595888

Other Identifiers

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SFLVRCT-2020

Identifier Type: -

Identifier Source: org_study_id

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