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

July 24, 2022 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visual acuity assessment 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
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
The presenting visual acuity will be assessed using the "Peek Acuity" application.
Other: Visual acuity assessment 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
Time Frame: Through study completion [an average of 6 months]
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
Time Frame: Through study completion [an average of 6 months]
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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