Accommodation Response in Hypermetropic Anisometropia (ARIHA Study)

Accommodation Disorder Clinical Trial

— ARIHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286410
• Other study ID #: 184950
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Sheffield
• Contact: Holly Geraghty
• Phone: 07757277466
• Email: hgeraghty[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Accommodation Disorder
• Amblyopia
• Anisometropia
• Anisometropic Amblyopia

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.

Locations

Country	Name	City	State
United Kingdom	Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Sheffield	Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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