- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936100
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99424
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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