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

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.

Study Overview

• Status: Completed
• Conditions: Blindness; Vision Impairment
• Intervention / Treatment: Device: Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application; Device: Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application; Device: Assessment of distance and near visual acuity using "Peek Acuity" application; Other: Assessment of distance and near visual acuity using the conventional methods

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Age ≥10 years old

Exclusion criteria:

• Subjects who are not able to respond to the examiner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual acuity assessment using "Vision Screening module" of "Easy Vision" application	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.
Experimental: Visual acuity assessment using "Test Yourself module" of "Easy Vision" application	Device: 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.
Experimental: Visual acuity assessment using "Peek Acuity" application	Device: Assessment of distance and near visual acuity using "Peek Acuity" application; The presenting visual acuity will be assessed using the "Peek Acuity" application.
Other: Visual acuity assessment using the conventional methods	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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]
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]

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Smartphone; Visual acuity
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness
• Other Study ID Numbers: 99424

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No