Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children

July 31, 2024 updated by: Ahmed Ali Amer, South Valley University
This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Visual impairment is an important public health issue worldwide, with a heavy socioeconomic burden. More than 400 million people globally have mild to severe visual impairment.

Visual acuity (VA) screening is the most basic part of ophthalmic examination. Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Knowing a patient's VA can help ophthalmologists remotely triage acute calls, monitor visual recovery after medical or surgical interventions, and ensure visual stability in follow-up telemedicine visits.

Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Numerous electronic home vision assessment tools exist, but many of these are used through applications on mobile or tablet devices.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Qinā, Egypt, 83523
        • Recruiting
        • South Valley University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This cross-sectional study will be carried out on 80 myopic children aged ≤ 18 years, who completed the home visual acuity test and have a subsequent office-based VA test at South Valley University for a period from July 2024 to January 2025 after approval from the institutional ethical committee.

Description

Inclusion Criteria:

  • Age ≤ 18 years.
  • Both sexes.
  • Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.

Exclusion Criteria:

  • Last in-office visual acuity of 20/125 or worse in both eyes (to allow for a buffer of at least 2 lines of vision from the upper limit of 20/200 on the home vision assessment).
  • Lack of access to MyChart.
  • History of keratopathy, cataract, glaucoma, retinal detachment, neuro-ophthalmic disease, or other eye diseases.
  • History of ophthalmic surgery or trauma.
  • History of systemic diseases.
  • Severe psychological or psychiatric diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Visual Acuity Testing group

Home vision assessment will be conducted using the "Letter Distance Chart" PDF document, a modified Early Treatment of Diabetic Retinopathy Study (ETDRS) chart for testing at 5 or 10 feet, and released for public use.

Patients will be asked to use the 5-foot distance for standardization, which allows for visual acuity assessment from 20/16 to 20/200.

Patients will be asked to wear their current corrective lens for distance, to take the test at home in a place with good lighting, and to test each eye separately.

Office-based vision testing will be performed by a trained ophthalmic technician in a dimmed room with the Snellen chart illuminated on a screen. Patients will be asked to wear their current corrective lens for distance and an eye occluder will be used to test each eye separately.
Other: Snellen chart

Patients will be asked to use the 5 feet distance for standardization, which allows for visual acuity assessment from 20/16 to 20/200.

Patients will be asked to wear their current corrective lens for distance, to take the test at home in a place with good lighting and to test each eye separately.

Office-based vision testing will be performed by a trained ophthalmic technician in a dimmed room with the Snellen chart illuminated on a screen. Patients will be asked to wear their current corrective lens for distance and an eye occluder will be used to test each eye separately.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement of visual acuity between office and home
Time Frame: immediately after test performing
Agreement of visual acuity between office and home will be assessed.
immediately after test performing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVU\MED\OPH026/4/24/7/887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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