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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04936100
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 16.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vision Impairment; Blindness	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
• Actual Study Start Date: Jun 23, 2021
• Actual Primary Completion Date: Dec 23, 2021
• Actual Study Completion Date: Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visual acuity assessment using "Vision Screening module" of "Easy Vision" application	Device: 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.
Experimental: Visual acuity assessment using "Test Yourself module" of "Easy Vision" application	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.
Experimental: Visual acuity assessment using "Peek Acuity" application	Device: Assessment of distance and near visual acuity using "Peek Acuity" application; The presenting visual acuity will be assessed using the "Peek Acuity" application.
Other: Visual acuity assessment using the conventional methods	Other: 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]

Outcome Measures

Primary Outcome Measures

1. Distance visual acuity assessment with Easy Vision versus Peek Acuity versus conventional distance visual acuity chart [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)

2. Near visual acuity assessment with Easy Vision versus Peek Acuity versus conventional near visual acuity chart [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Age ≥10 years old

Exclusion criteria:

• Subjects who are not able to respond to the examiner

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zahra Rabbani Khah, Head of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04936100
• Other Study ID Numbers: 99424
• First Posted: Jun 23, 2021
• Last Update Posted: Jul 27, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zahra Rabbani Khah, Head of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences: Visual acuity; Smartphone
• Additional relevant MeSH terms: Blindness

Study Results

No Results Posted as of Jul 27, 2022