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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03310216
Other study ID # CCPMOH2017-China-8
Secondary ID
Status Recruiting
Phase N/A
First received October 10, 2017
Last updated October 10, 2017
Start date October 2017
Est. completion date December 2017

Study information

Verified date October 2017
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Order I of visual inspection
Participants in group I are provided AI visual inspection system first and EDTRS later.
Order II of visual inspection
The participants in Group II are provided EDTRS first and AI visual inspection system later.

Locations

Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The accuracy of AI visual inspection system The accuracy of AI visual inspection system was calculated. Baseline
Secondary The time taken of visual inspection The time taken of visual inspection was calculated. Baseline
Secondary Costs of AI visual inspection system Costs of AI visual inspection system was calculated. Baseline
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