Accommodation Response in Hypermetropic Anisometropia (ARIHA Study)

Launched by UNIVERSITY OF SHEFFIELD · Feb 22, 2024

Keywords

ClinConnect Summary

The ARIHA Study is a clinical trial designed to better understand and improve treatment for children aged 4 to 10 who have a specific vision condition called hypermetropic anisometropic amblyopia. This condition happens when one eye has a much weaker prescription than the other, leading to poor vision in the weaker eye, even with glasses. The study aims to find out if measuring how well the weaker eye can focus (using a special device) can help doctors adjust glasses prescriptions to improve vision outcomes.

To participate in this trial, children must be between 4 and 10 years old and already receiving standard treatment for their condition, such as wearing glasses or using eye patches or drops. The trial has two phases: the first phase involves measuring how well the child's eyes focus during standard treatment, and the second phase tests whether changing their glasses based on these measurements can enhance their vision. This research could lead to better treatment options for children experiencing similar vision challenges in the future.

Gender

ALL

Eligibility 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