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

NCT06529367 | Recruiting

• 1 other identifier: SVU\MED\OPH026/4/24/7/887
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.

Conditions

Home Vision; Office-Based Snellen Visual Acuity; Myopic Children

Outcome Measures

Primary Outcomes (1)

• Agreement of visual acuity between office and home

  Agreement of visual acuity between office and home will be assessed.

  immediately after test performing

Study Arms (1)

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

Interventions

Snellen chart OTHER

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.

Visual Acuity Testing group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, 83523, Egypt

RECRUITING

Central Study Contacts

Ahmed A Amer, MD

CONTACT

00201011827000; ahmedali.ophth@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology, Faculty of Medicine, South Valley University, Qena, Egypt.

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: July 31, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)