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The acceptance of spectacle lenses designed to manage short-sightedness in children with unequal spectacle prescriptions

Evaluation of the clinical acceptance of novel myopia management spectacle lenses in anisometropic children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17297434
Enrollment
48
Registered
2024-06-25
Start date
2024-06-24
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia Eye Diseases

Interventions

This dispensing study aims to investigate the clinical acceptance and long-term impact of myopia management spectacle lenses (DOT 0.2) on axial length and choroidal thickness in anisometropic children

Sponsors

Aston University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 6 to 12 years old 2. Spectacle prescription: Myopic (=-0.50 DS to =-2.00 DS Mean spherical equivalent (MSE) in one eye and near Plano (+0.50 to -0.50 DS) in the contralateral eye by cycloplegic autorefraction 3. Astigmatism <1.00 DC by cycloplegic autorefraction 4. Best corrected level of visual acuity of at least 0.1 logMAR

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Visual acuity (VA) measured using high- and low-contrast conditions using a logMAR visual acuity chart at screening (visit 1), baseline (visit 2), and at follow-ups at 3, 6 and 12 months (visits 3, 4, and 5)

Secondary

MeasureTime frame
1. Axial length (length of the eye) will be measured using non-contact biometry (IOLMaster 500/700) using standard operating procedures at baseline (visit 2), and at follow-ups at 3, 6 and 12 months (visits 3, 4, and 5) 2. Choroidal thickness measured using a non-contact spectral domain optical coherence tomography at baseline (visit 2), and at follow-ups at 3, 6 and 12 months (visits 3, 4, and 5)

Countries

England, United Kingdom

Contacts

Public ContactJames Wolffsohn
j.s.w.wolffsohn@aston.ac.uk+44 (0)121 204 3900

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026