Back to resultsAssessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
Primary Purpose
Vision Impairment, Blindness
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application
Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application
Assessment of distance and near visual acuity using "Peek Acuity" application
Assessment of distance and near visual acuity using the conventional methods
Sponsored by
About this trial
This is an interventional health services research trial for Vision Impairment focused on measuring Visual acuity, Smartphone
Eligibility Criteria
Inclusion criteria:
• Age ≥10 years old
Exclusion criteria:
• Subjects who are not able to respond to the examiner
Sites / Locations
- Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Visual acuity assessment using "Vision Screening module" of "Easy Vision" application
Visual acuity assessment using "Test Yourself module" of "Easy Vision" application
Visual acuity assessment using "Peek Acuity" application
Visual acuity assessment using the conventional methods
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04936100
First Posted
April 25, 2021
Last Updated
July 24, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04936100
Brief Title
Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
Official Title
Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Impairment, Blindness
Keywords
Visual acuity, Smartphone
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual acuity assessment using "Vision Screening module" of "Easy Vision" application
Arm Type
Experimental
Arm Title
Visual acuity assessment using "Test Yourself module" of "Easy Vision" application
Arm Type
Experimental
Arm Title
Visual acuity assessment using "Peek Acuity" application
Arm Type
Experimental
Arm Title
Visual acuity assessment using the conventional methods
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" application
Intervention Description
The presenting visual acuity will be assessed using the Vision Screening module of the "Easy Vision" application.
Intervention Type
Device
Intervention Name(s)
Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application
Intervention Description
The presenting visual acuity will be assessed using the Test Yourself module of the "Easy Vision" application.
Intervention Type
Device
Intervention Name(s)
Assessment of distance and near visual acuity using "Peek Acuity" application
Intervention Description
The presenting visual acuity will be assessed using the "Peek Acuity" application.
Intervention Type
Other
Intervention Name(s)
Assessment of distance and near visual acuity using the conventional methods
Intervention Description
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]
Primary Outcome Measure Information:
Title
Distance visual acuity assessment with Easy Vision versus Peek Acuity versus conventional distance visual acuity chart
Description
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)
Time Frame
Through study completion [an average of 6 months]
Title
Near visual acuity assessment with Easy Vision versus Peek Acuity versus conventional near visual acuity chart
Description
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)
Time Frame
Through study completion [an average of 6 months]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
• Age ≥10 years old
Exclusion criteria:
• Subjects who are not able to respond to the examiner
Facility Information:
Facility Name
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
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