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

October 10, 2017 updated by: Haotian Lin, Sun Yat-sen University

The Clinical Application of Artificial Intelligent Visual Inspection System

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Principal Investigator:
          • Haotian Lin, M.D,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 86 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Order I of visual inspection
Participants in group I are provided AI visual inspection system first and EDTRS later.
Procedure: Order I of visual inspection
Participants in group I are provided AI visual inspection system first and EDTRS later.
Active Comparator: Order II of visual inspection
Participants in group II are provided EDTRS first and AI visual inspection system later.
Procedure: Order II of visual inspection
The participants in Group II are provided EDTRS first and AI visual inspection system later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of AI visual inspection system
Time Frame: Baseline
The accuracy of AI visual inspection system was calculated.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time taken of visual inspection
Time Frame: Baseline
The time taken of visual inspection was calculated.
Baseline
Costs of AI visual inspection system
Time Frame: Baseline
Costs of AI visual inspection system was calculated.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCPMOH2017-China-8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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