Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286410
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-02-22
Brief Title:
Accommodation Response in Hypermetropic Anisometropia ARIHA Study
Sponsor:
University of Sheffield
Organization:
University of Sheffield
Study Overview
Official Title:
Accommodation Response in Hypermetropic Anisometropia ARIHA Study Accommodation Changes During Amblyopia Treatment and Pilot Residual Amblyopia Treatment Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARIHA
Brief 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 werent 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 Childrens 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
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 werent 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 Childrens 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None