NCT03310216

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 10, 2017

Last Update Submit

October 10, 2017

Conditions

Ophthalmology

Keywords

artificial intelligentvisual inspection

Outcome Measures

Primary Outcomes (1)

  • The accuracy of AI visual inspection system

    The accuracy of AI visual inspection system was calculated.

    Baseline

Secondary Outcomes (2)

  • The time taken of visual inspection

    Baseline

  • Costs of AI visual inspection system

    Baseline

Study Arms (2)

Order I of visual inspection

EXPERIMENTAL

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

Procedure: Order I of visual inspection

Order II of visual inspection

ACTIVE COMPARATOR

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

Procedure: Order II of visual inspection

Interventions

Order I of visual inspectionPROCEDURE

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

Order I of visual inspection
Order II of visual inspectionPROCEDURE

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

Order II of visual inspection

Eligibility Criteria

Age1 Month - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 16, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

CN(1)