Accommodation Response in Hypermetropic Anisometropia (ARIHA Study) (ARIHA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Accommodation Disorder; Anisometropic Amblyopia
• Intervention / Treatment: Other: Bespoke glasses prescription worn during amblyopia treatment.

Detailed Description

This is a two-phase study of children aged 4-10 years who have hypermetropic anisometropia:

1. Phase 1 is a cohort observational study. It will involve repeated measurements of accommodation response (using the PR3) of hypermetropic anisometropic children during their standard care treatment at SCH. PR3 measurements (all non-invasive) will be taken at various stages of their treatment to track if accommodation responses change over time.
2. Phase 2 is a pilot intervention study. It will recruit hypermetropic anisometropic children who have finished their standard care treatment at SCH but have not achieved equal (or nearly equal) vision for initial screening. Those who are found to have asymmetrical accommodation responses, and also have residual amblyopia (unequal vision in the two eyes) will be invited to the intervention study. Bespoke glasses will be issued, based on accommodation response, and children will restart occlusion (patching) for 12 weeks while wearing the bespoke glasses. This is to assess whether a glasses adaptation based on accommodation response will help to further improve vision in their amblyopic eye.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holly Geraghty; Phone Number: 07757277466; Email: hgeraghty@sheffield.ac.uk
• Study Contact Backup: Name: Gemma Arblaster; Phone Number: 0114 215 9005; Email: g.arblaster@sheffield.ac.uk

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2RX
      • Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield
      • Contact: Gemma Arblaster; Phone Number: 0114 215 9005; Email: g.arblaster@sheffield.ac.uk
      • Contact: Holly Geraghty; Phone Number: 0114 215 9005; Email: hgeraghty@sheffield.ac.uk
      • Principal Investigator: Holly Geraghty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity	The change found in level of visual acuity pre- and post- pilot intervention in the amblyopic eye (phase 2).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PR3 accommodation measurements	The changes in PR3 accommodation measurements during standard care treatment in hypermetropic anisometropic amblyopia and the amount of participants found to have asymmetrical accommodation and residual amblyopia (both Phase 1).	12 weeks

Collaborators and Investigators

• Sponsor: University of Sheffield
• Collaborators: Sheffield Children's NHS Foundation Trust
• Investigators: Principal Investigator: Holly Geraghty, University of Sheffield

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Amblyopia; Accommodation; Anisometropia; Anisometropic Amblyopia; Plusoptix PowerRefractor 3; Anti-accommodation; Anisometropic accommodation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders; Amblyopia; Anisometropia
• Other Study ID Numbers: 184950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No