Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06286410 |
| Other study ID # |
184950 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
