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

NCT ID: NCT04936100

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2022-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vision Impairment Blindness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Visual acuity assessment using "Peek Acuity" application

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Visual acuity assessment using the conventional methods

Group Type OTHER

Assessment of distance and near visual acuity using the conventional methods

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Assessment of distance and near visual acuity using the conventional methods

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Age ≥10 years old

Exclusion Criteria

• Subjects who are not able to respond to the examiner
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of Ophthalmic Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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99424

Identifier Type: -

Identifier Source: org_study_id

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