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The Clinical Application of Artificial Intelligent(AI) Visual Inspection System

NCT ID: NCT03310216

Last Updated: 2017-10-16

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2017-12-31

Brief Summary

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In this study, the investigators provide participants from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection system and EDTRS for visual inspection.

Detailed Description

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Patients ≤90 years old from ophthalmic clinic are enrolled to a prospective, randomized controlled study. Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later. All of the visual inspection methods will be repeated two times. Investigators compare the accuracy and repeatability of the AI visual inspection system, time consuming, costs and the satisfaction level between two groups.

Conditions

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Ophthalmology

Keywords

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artificial intelligent visual inspection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Order I of visual inspection

Participants in group I are provided AI visual inspection system first and EDTRS later.

Group Type EXPERIMENTAL

Order I of visual inspection

Intervention Type PROCEDURE

Participants in group I are provided AI visual inspection system first and EDTRS later.

Order II of visual inspection

Participants in group II are provided EDTRS first and AI visual inspection system later.

Group Type ACTIVE_COMPARATOR

Order II of visual inspection

Intervention Type PROCEDURE

The participants in Group II are provided EDTRS first and AI visual inspection system later.

Interventions

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Order I of visual inspection

Participants in group I are provided AI visual inspection system first and EDTRS later.

Intervention Type PROCEDURE

Order II of visual inspection

The participants in Group II are provided EDTRS first and AI visual inspection system later.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients≤90 years old from ophthalmic clinic; Written informed consents provided

Exclusion Criteria

* Can not cooperate with the visual inspection; Unwilling to participate in this trail
Minimum Eligible Age

1 Month

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jing Li, M.D

Role: primary

Other Identifiers

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CCPMOH2017-China-8

Identifier Type: -

Identifier Source: org_study_id