Home VisionNCT06529367
Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
An observational study of Home Vision and Office-Based Snellen Visual Acuity, run by South Valley University at 1 site in Egypt.
Trial summary
This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Home Vision, Office-Based Snellen Visual Acuity, Myopic Children
- What is being tested?
- Snellen chart
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jul 2024to 1 Feb 2025
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age ≤ 18 years.
- Both sexes.
- Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University
Qina, 83523
Ahmed A Amer, MD, 00201011827000, ahmedali.ophth@gmail.com
About this study
This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.
Read the 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.
- Being tested
- Snellen chart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snellen chartOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Snellen chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of visual acuity between office and home
Agreement of visual acuity between office and home will be assessed.
Measured: immediately after test performing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home VisionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Amer, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529367
- Sponsor's protocol ID
- SVU\MED\OPH026/4/24/7/887
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
- ClinicalTrials.gov ID
- NCT06529367
- Acronym / sponsor ID
- SVU\MED\OPH026/4/24/7/887
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 31 Jul 2024 (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.
This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Acuity Testing group | – | Other: Snellen chartHome 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Age ≤ 18 years.
- Both sexes.
- Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Snellen chartPatients 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. | Other | Visual Acuity Testing group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Vision and Office-Based Snellen Visual Acuity, run by South Valley University at 1 site in Egypt.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Amer, MD (00201011827000, ahmedali.ophth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of visual acuity between office and home (time frame: immediately after test performing). 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 1 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.