An interventional study of Bespoke glasses prescription worn during amblyopia treatment. in Anisometropic Amblyopia and Accommodation Disorder, sponsored by University of Sheffield. Recruiting at 1 site in United Kingdom. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Sheffield · Not applicable, Interventional, and Treatment
Among 11 studies in Amblyopia with a site in United Kingdom — 3 open to participants now, 3 under way, none of them phase 3. Amblyopia · United Kingdom.
Among the 11 studies in Amblyopia with a site in United Kingdom, this one is one of 2 that started in 2024, is one of 6 with no phase, and was the 10th registered.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
Browse Amblyopia studies →3 of the 11 studies in Amblyopia with a site in United Kingdom are open now. Recruiting first, the newest first:
Guy's and St Thomas' NHS Foundation Trust · Sites in United Kingdom
Moorfields Eye Hospital NHS Foundation Trust · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 30 Amblyopia studies recruiting now, 4 (13%) set no upper age limit and 24 (80%) stop at 75 or younger; 25 take children under 18; 7 take healthy volunteers.
This study: 4 Years to 10 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 22 is below the median of 60 across 137 interventional studies indexed under Amblyopia.
Median enrollment 75 across the 9 interventional studies, 378 across the 2 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 10 most frequent:
University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.
University of Sheffield has 1 study filed under Amblyopia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Amblyopia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
This is a two-phase study of children aged 4-10 years who have hypermetropic anisometropia:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1
Phase 2
Exclusion Criteria:
Phase 1 and Phase 2
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Change in visual acuity
The change found in level of visual acuity pre- and post- pilot intervention in the amblyopic eye (phase 2).
Time frame: 12 weeks
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).
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2024, 8 months after the start.
Of 58 non-industry interventional studies with no phase under Amblyopia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's planned 8 months is below that.
Counting every sponsor, half of 71 studies reached it within 33 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sheffield