Vision ImpairmentNCT04936100
Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
A study testing 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 and Assessment of distance and near visual acuity using "Peek Acuity" application in people with Vision Impairment and Blindness, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Impairment, Blindness
- What is being tested?
- 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 and Assessment of distance and near visual acuity using "Peek Acuity" application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 23 Jun 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥10 years old
Who cannot join
- Subjects who are not able to respond to the examiner
Trial locations and contacts
1 site in 1 country.
Iran1 site
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Tehran
About this study
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
- Being tested
- 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
- Keywords
- Visual acuity, Smartphone
- Medical subject headings
- Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" applicationDevice
The presenting visual acuity will be assessed using the Vision Screening module of the "Easy Vision" application.
Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" applicationDevice
The presenting visual acuity will be assessed using the Test Yourself module of the "Easy Vision" application.
Assessment of distance and near visual acuity using "Peek Acuity" applicationDevice
The presenting visual acuity will be assessed using the "Peek Acuity" application.
Assessment of distance and near visual acuity using the conventional methodsOther
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]
| Study group | Role | What they receive |
|---|---|---|
| Visual acuity assessment using "Vision Screening module" of "Easy Vision" application | Experimental | Not described Receives: 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 | Not described Receives: Device: Assessment of distance and near visual acuity using "Test Yourself module" of "Easy Vision" application |
| Visual acuity assessment using "Peek Acuity" application | Experimental | Not described Receives: Device: Assessment of distance and near visual acuity using "Peek Acuity" application |
| Visual acuity assessment using the conventional methods | Other | Not described Receives: Other: Assessment of distance and near visual acuity using the conventional methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Through study completion [an average of 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start23 Jun 2021
- Primary completion23 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936100
- Sponsor's protocol ID
- 99424
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
- ClinicalTrials.gov ID
- NCT04936100
- Acronym / sponsor ID
- 99424
- Conditions
- Vision Impairment, Blindness
- Keywords
- Visual acuity, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥10 years old
Key exclusion criteria (1 listed)
- Subjects who are not able to respond to the examiner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of distance and near visual acuity using "Vision Screening module" of "Easy Vision" applicationThe presenting visual acuity will be assessed using the Vision Screening module of the "Easy Vision" application. | Device | 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" applicationThe presenting visual acuity will be assessed using the Test Yourself module of the "Easy Vision" application. | Device | Visual acuity assessment using "Test Yourself module" of "Easy Vision" application |
| Assessment of distance and near visual acuity using "Peek Acuity" applicationThe presenting visual acuity will be assessed using the "Peek Acuity" application. | Device | Visual acuity assessment using "Peek Acuity" application |
| Assessment of distance and near visual acuity using the conventional methodsThe 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] | Other | Visual acuity assessment using the conventional methods |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Assessment of distance and near visual acuity using "Peek Acuity" application in people with Vision Impairment and Blindness, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.