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

NCT04936100 | Completed

• 1 other identifier: 99424
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vision Impairment; Blindness

Keywords

Visual acuity; Smartphone

Outcome Measures

Primary Outcomes (2)

• 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]

Study Arms (4)

Visual acuity assessment using "Vision Screening module" of "Easy Vision" application

EXPERIMENTAL

Device: Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application

Visual acuity assessment using "Test Yourself module" of "Easy Vision" application

EXPERIMENTAL

Device: Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application

Visual acuity assessment using "Peek Acuity" application

EXPERIMENTAL

Device: Assessment of distance and near visual acuity using "Peek Acuity" application

Visual acuity assessment using the conventional methods

OTHER

Other: Assessment of distance and near visual acuity using the conventional methods

Interventions

Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application DEVICE

The presenting visual acuity will be assessed using the Vision Screening module of the "Easy Vision" application.

Visual acuity assessment using "Vision Screening module" of "Easy Vision" application

Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application DEVICE

The presenting visual acuity will be assessed using the Test Yourself module of the "Easy Vision" application.

Visual acuity assessment using "Test Yourself module" of "Easy Vision" application

Assessment of distance and near visual acuity using "Peek Acuity" application DEVICE

The presenting visual acuity will be assessed using the "Peek Acuity" application.

Visual acuity assessment using "Peek Acuity" application

Assessment of distance and near visual acuity using the conventional methods OTHER

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

Visual acuity assessment using the conventional methods

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥10 years old

You may not qualify if:

• Subjects who are not able to respond to the examiner

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Vision Disorders; Blindness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: June 23, 2021
• Study Start: June 23, 2021
• Primary Completion: December 23, 2021
• Study Completion: January 30, 2022
• Last Updated: July 27, 2022

Record last verified: 2021-04

Locations

IR (1)