Vision in children with spectacle lenses designed to manage short-sightedness

Not Applicable

• Conditions: Myopia; Eye Diseases

• Registration Number: ISRCTN20591209
• Lead Sponsor: Aston University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-12
• Last Update Posted: 8 January 2024
• Study Completion: 2025-03-13

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age range: 6 to 12 years
2. Spectacle prescription: myopic (mean spherical equivalent [MSE] =-0.50 DS to <-8.00 DS) by cycloplegic autorefraction
3. Astigmatism <2.00 DC by cycloplegic autorefraction
4. Anisometropia =2.00 D (MSE) by cycloplegic autorefraction
5. Best corrected level of visual acuity of at least 0.00 logMAR

Exclusion Criteria

1. Aphakic or pseudophakic
2. Binocular vision problems (e.g., amblyopia, strabismus, nystagmus etc)
3. Any current or evolving ocular pathology
4. Any previous ocular surgery
5. Any systemic condition which might have an influence on vision or visual function
6. Any medical treatment or medication which might have an influence on vision or visual function
7. Is/ has received any myopia management treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity (VA) is measured under high- and low-contrast conditions using a logMAR visual acuity chart for each device after a 7-day wearing period

Secondary Outcome Measures

Name	Time	Method
Sub-foveal choroidal thickness is measured under using a non-contact spectral domain optical coherence tomographer for each device after a 7-day wearing period