CClinicalTrials.gg
Status unknownNCT03310216AIUpdated Oct 16, 2017

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

An interventional study of Order I of visual inspection and Order II of visual inspection in Ophthalmology, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 1 Month to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Month to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ophthalmology

Keywords

  • artificial intelligent
  • visual inspection
03

Who can participate

Ages eligible
1 Month to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Can not cooperate with the visual inspection; Unwilling to participate in this trail
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureOrder I of visual inspection

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

  • ProcedureOrder II of visual inspection

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

05

What researchers measure

Primary outcomes

  1. The accuracy of AI visual inspection system

    The accuracy of AI visual inspection system was calculated.

    Time frame: Baseline

Secondary outcomes

  1. The time taken of visual inspection

    The time taken of visual inspection was calculated.

    Time frame: Baseline

  2. Costs of AI visual inspection system

    Costs of AI visual inspection system was calculated.

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510060, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03310216
Lead sponsor
Sun Yat-sen University
Responsible party
Haotian Lin (Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Oct 16, 2017
Start date
Oct 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Oct 16, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion