Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity

Blindness Clinical Trial

Official title:

Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936100
• Other study ID #: 99424
• Status: Completed
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: April 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Visual acuity (VA) is the most common measure of visual function globally. In clinical settings and during screening events, VA is an important measure to quantify changes in vision over time. Additionally, in the context of epidemiological studies and population-based surveys, VA is a critical measure to determine the presence and degree of vision impairment and to report on the indicators of effective eye care service coverage (i.e. refractive error and cataract surgery), that are currently considered by World Health Organization (WHO) for monitoring progress towards the Universal Health Coverage.

There are numerous applications for assessing VA; however, the number of validated applications is limited. In this study, the investigators aim to evaluate the external validity, intra- and inter-observer reliability, and feasibility of two applications ("Easy Vision" and "Peek Acuity") for testing the visual acuity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2022
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion criteria:

• Age =10 years old

Exclusion criteria:

• Subjects who are not able to respond to the examiner

Related Conditions & MeSH terms

• Blindness
• Vision Impairment

Intervention

Device:
• Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application
The presenting visual acuity will be assessed using the Vision Screening module of the "Easy Vision" application.
• Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application
The presenting visual acuity will be assessed using the Test Yourself module of the "Easy Vision" application.
• Assessment of distance and near visual acuity using "Peek Acuity" application
The presenting visual acuity will be assessed using the "Peek Acuity" application.

Other:
• Assessment of distance and near visual acuity using the conventional methods
The presenting visual acuity will be assessed using the conventional methods ["Chart: Tumbling E optotype" for assessing distance visual acuity and "Handheld chart: Tumbling E Near Point Vision Chart" for assessing near visual acuity]

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance visual acuity assessment with Easy Vision versus Peek Acuity versus conventional distance visual acuity chart	To assess the agreement between two smartphone-based evaluation of distance visual acuity (LogMAR unit) with Easy Vision and Peek Acuity and a conventional distance visual acuity chart (Tumbling E optotype)	Through study completion [an average of 6 months]
Primary	Near visual acuity assessment with Easy Vision versus Peek Acuity versus conventional near visual acuity chart	To assess the agreement between two smartphone-based evaluation of near visual acuity (LogMAR unit) with Easy Vision and Peek Acuity and a conventional near visual acuity chart (Handheld chart: Tumbling E Near Point Vision Chart)	Through study completion [an average of 6 months]