Anisometropic AmblyopiaARIHANCT06286410
Accommodation Response in Hypermetropic Anisometropia (ARIHA Study)
A study testing Bespoke glasses prescription worn during amblyopia treatment. in people with Anisometropic Amblyopia and Accommodation Disorder, run by University of Sheffield at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anisometropic Amblyopia, Accommodation Disorder
- What is being tested?
- Bespoke glasses prescription worn during amblyopia treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield
Sheffield, South Yorkshire, S10 2RX
Holly Geraghty, 0114 215 9005, hgeraghty@sheffield.ac.uk
Gemma Arblaster, 0114 215 9005, g.arblaster@sheffield.ac.uk
About this study
Official title: 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.
Read more
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.
Read the detailed description
This is a two-phase study of children aged 4-10 years who have hypermetropic anisometropia:
- 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.
- 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.
- Conditions
- Anisometropic Amblyopia, Accommodation Disorder
- Being tested
- Bespoke glasses prescription worn during amblyopia treatment.
- Keywords
- Anisometropia, Amblyopia, Anisometropic Amblyopia, Accommodation, Plusoptix PowerRefractor 3, Anti-accommodation, Anisometropic accommodation
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bespoke glasses prescription worn during amblyopia treatment.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Aniso-A | Experimental | 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. Receives: Other: Bespoke glasses prescription worn during amblyopia treatment. |
| Anti-A | Experimental | 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. Receives: Other: Bespoke glasses prescription worn during amblyopia treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
The change found in level of visual acuity pre- and post- pilot intervention in the amblyopic eye (phase 2).
Measured: 12 weeks
Secondary outcomes (1)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start11 Apr 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anisometropic AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- During Phase 2 of the study: The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient. Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Holly Geraghty, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286410
- Sponsor's protocol ID
- 184950
- Acronym
- ARIHA
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accommodation Response in Hypermetropic Anisometropia (ARIHA) Study: Accommodation Changes During Amblyopia Treatment and Pilot Residual Amblyopia Treatment Study
- ClinicalTrials.gov ID
- NCT06286410
- Acronym / sponsor ID
- ARIHA / 184950
- Conditions
- Anisometropic Amblyopia, Accommodation Disorder
- Keywords
- Anisometropia, Amblyopia, Anisometropic Amblyopia, Accommodation, Plusoptix PowerRefractor 3, Anti-accommodation, Anisometropic accommodation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-phase study of children aged 4-10 years who have hypermetropic anisometropia:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During Phase 2 of the study: The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient. Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A.
| Arm | Type | Receives |
|---|---|---|
| Aniso-A | Experimental | Other: Bespoke glasses prescription worn during amblyopia treatment.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. |
| Anti-A | Experimental | 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Aniso-A, Anti-A |
Primary outcome
Change in visual acuity
Time frame: 12 weeks
The change found in level of visual acuity pre- and post- pilot intervention in the amblyopic eye (phase 2).
1 secondary outcome
Change in PR3 accommodation measurements
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Geraghty principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bespoke glasses prescription worn during amblyopia treatment. in people with Anisometropic Amblyopia and Accommodation Disorder, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly Geraghty (07757277466, hgeraghty@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.