Accommodation Response in Hypermetropic Anisometropia (ARIHA) Study: Accommodation Changes During Amblyopia Treatment and Pilot Residual Amblyopia Treatment Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye. With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others. Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics. The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 10
Healthy Volunteers: t
View:

⁃ 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)

Locations
Other Locations
United Kingdom
Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield
RECRUITING
Sheffield
Contact Information
Primary
Holly Geraghty
hgeraghty@sheffield.ac.uk
07757277466
Backup
Gemma Arblaster
g.arblaster@sheffield.ac.uk
0114 215 9005
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2024-12
Participants
Target number of participants: 22
Treatments
Experimental: Aniso-A
Aniso-A~Those found to have anisometropic accommodation response do not focus effectively in their amblyopic eye when looking at the 0.33m (near) targets. Aniso-A response will be determined by their interocular difference in measurements at near (0.33m).~They will be given a prescription for D-28 segment bifocal glasses. The distance section of the glasses will match their current glasses, and the bifocal add will be equivalent to the mean amount they are under accommodating by at 0.33m in their amblyopic eye during the cue conditions with glasses. Bifocals will only be worn during patching. They will wear their own current glasses for all other times. This will be made very clear to parents/caregivers, and written instructions will be given.~The participant will act as their own controls: visual acuity at recruitment will be used to compare to visual acuity during and after the intervention.
Experimental: Anti-A
Anti-A~Those found to have anti-accommodation over-accommodate in their amblyopic eye for the 2m (distance) target. Aniso-A response will be determined by their interocular difference in measurement in the distance (2m).~They will be given a prescription for single vision distance glasses. The distance prescription in their non-amblyopic eye will be the same as their current glasses. The distance prescription in their amblyopic eye will be reduced by the same amount they are over-accommodating by during the cue conditions with glasses. This amended distance prescription will only be worn during patching. They will wear their own current glasses for all other times. This will be made very clear to parents/caregivers, and written instructions will be given.~The participant will act as their own controls: visual acuity at recruitment will be used to compare to visual acuity during and after the intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Sheffield Children's NHS Foundation Trust
Leads: University of Sheffield

This content was sourced from clinicaltrials.gov