Assessing vision improvement in children with anisometropic amblyopia using bespoke glasses
Accommodation Response in Hypermetropic Anisometropia (ARIHA) Study: Accommodation Changes During Amblyopia Treatment and Pilot Residual Amblyopia Treatment Study
NA · University of Sheffield · NCT06286410
This study is testing if specially designed glasses can help children aged 4-10 with uneven vision due to a specific type of lazy eye feel better after their regular treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | University of Sheffield (other) |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT06286410 on ClinicalTrials.gov |
What this trial studies
This study investigates the accommodation response in children aged 4-10 years with hypermetropic anisometropic amblyopia. It consists of two phases: the first phase is an observational study that measures accommodation responses using the Plusoptix PowerRefractor during standard treatment. The second phase is a pilot intervention where children who have completed standard treatment but still have unequal vision will receive bespoke glasses tailored to their accommodation response, along with continued occlusion therapy, to evaluate potential improvements in vision.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-10 years with hypermetropic anisometropic amblyopia and a significant difference in prescription between their eyes.
Not a fit: Patients with other eye conditions causing amblyopia or significant health issues affecting vision may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance visual outcomes for children with anisometropic amblyopia who currently do not respond well to standard treatments.
How similar studies have performed: While the use of accommodation measurement in this context is relatively novel, previous studies have shown promise in improving treatment outcomes for amblyopia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Phase 1 * 4-10 years (at recruitment) * Have hypermetropic anisometropia with ≥1.00D of difference (in spherical equivalent) * Are currently undergoing treatment for hypermetropic anisometropia (including refractive adaptation and/or occlusion treatment - patching or atropine) * Visual acuity in non-amblyopic eye ≤0.200 logMAR * Any level of VA in amblyopic eye (worse than non-amblyopic eye) * No manifest strabismus * Accept microT with/without identity * No other eye conditions as cause of amblyopia (e.g. stimulus deprivation amblyopia/strabismic amblyopia) * No significant health conditions that would impact vision or accommodation response (e.g. Down's Syndrome/Cerebral Palsy) * Informed consent from parent / guardian and assent from child (over 5 years) Phase 2 * 4-10 years (at recruitment) * Hypermetropic anisometropic amblyopes ≥1.00D of difference (in spherical equivalent) * Finished standard amblyopia occlusion treatment (including patching and/or atropine) * Asymmetric accommodation responses (Anti-A and Aniso-A) following preliminary assessment * VA in non-amblyopic eye ≤0.200 logMAR * Residual amblyopia (defined as interocular difference of ≥0.2 log units) * No manifest strabismus * Accept microT with/without identity * No other eye conditions as cause of amblyopia (e.g. stimulus deprivation amblyopia/strabismic amblyopia) * No significant health conditions that would impact vision or accommodation response (e.g. Down's Syndrome/Cerebral Palsy) * Informed consent from parent / guardian and assent from child (over 5 years) Exclusion Criteria: Phase 1 and Phase 2 * Not within the age range 4-10 years at time of recruitment * Has myopic anisometropia (either eye) * \<1.00D of hypermetropic anisometropia * Vision in non-amblyopic eye worse than \>0.200 logMAR * Has a manifest strabismus * Has amblyopia caused by an eye condition (e.g. stimulus deprivation amblyopia/strabismic amblyopia) * Has a significant health condition that would impact vision or accommodation response (e.g. Down's Syndrome/Cerebral Palsy) * Parent /guardian unable to give informed consent * Parent/guardian unable to communicate in English sufficiently to give informed consent * (Phase 2 only) does not have residual amblyopia (has equal vision in both eyes) * (Phase 2 only) has symmetrical accommodation on the PR3 tests
Where this trial is running
Sheffield, South Yorkshire
- Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield — Sheffield, South Yorkshire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Holly Geraghty — University of Sheffield
- Study coordinator: Holly Geraghty
- Email: hgeraghty@sheffield.ac.uk
- Phone: 07757277466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anisometropic Amblyopia, Accommodation Disorder, Anisometropia, Amblyopia, Accommodation, Plusoptix PowerRefractor 3, Anti-accommodation, Anisometropic accommodation