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Accommodation Response in Hypermetropic Anisometropia (ARIHA Study)

NCT06286410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-05-09

No results posted yet for this study

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.

Conditions

  • Anisometropic Amblyopia
  • Accommodation Disorder

Interventions

OTHER

Bespoke glasses prescription worn during amblyopia treatment.

The investigators aim to use the information they gather about a participant's accommodation response to be used in a bespoke glasses prescription that will be worn during amblyopia treatment. This is to try and improve vision in those with residual amblyopia following standard amblyopia treatment.

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    collaborator OTHER

  • University of Sheffield

    lead OTHER

Principal Investigators

  • Holly Geraghty · University of Sheffield

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286410 on ClinicalTrials.gov