protocolSection identificationModule nctId: NCT06286410, orgStudyIdInfo id: 184950, briefTitle: Accommodation Response in Hypermetropic Anisometropia (ARIHA Study), acronym: ARIHA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Sheffield, class: OTHER, collaborators name: Sheffield Children's NHS Foundation Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Anisometropic Amblyopia, conditions: Accommodation Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During Phase 2 of the study:The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient.Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Bespoke glasses prescription worn during amblyopia treatment., outcomesModule primaryOutcomes measure: Change in visual acuity, secondaryOutcomes measure: Change in PR3 accommodation measurements, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield, city: Sheffield, state: South Yorkshire, zip: S10 2RX, country: United Kingdom, contacts name: Holly Geraghty, role: CONTACT, phone: 0114 215 9005, email: hgeraghty@sheffield.ac.uk, contacts name: Gemma Arblaster, role: CONTACT, phone: 0114 215 9005, email: g.arblaster@sheffield.ac.uk, contacts name: Holly Geraghty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False