Testing Spectacles for amblyopia
Official title: Optical Correction and Visual Functions of Adults With Amblyopia
Spectacle Correction for the Treatment of Amblyopia
- 1 group
- One site, in Waterloo
- Recruiting
Interventions
- Medical device
Spectacles
Prescription of refractive error correction in spectacles. Refractive error to be determined as part of standard optometric eye exam (performed by registered optometrist). Guidelines for optical correction for the prescription of the study spectacles (based on Pediatric Eye Disease Investigator Group \[PEDIG\] amblyopia clinical trial protocols): Hypermetropia: not undercorrected by \>+1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. Anisometropia: full correction of the anisometropic difference. Astigmatism: cylinder power in each eye should be within ≤±0.50D of fully correcting the astigmatism for each eye. If cylinder power is ≥1.00D, the prescribed axis in both eyes should be within ≤±6 deg of the cycloplegic refraction axis. Appropriate refractive error correction will be prescribed. Participants will be instructed to wear the optical correction full-time (i.e., \>50% of waking hours) for the duration of the study.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Waterloo
Waterloo, Ontario
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18-39 (inclusive) years of age
- +Anisometropic amblyopia (difference of ≥0.50D spherical equivalent or ≥1.50D astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia)
- +Best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 logMAR to 1.0 logMAR (inclusive)
- +BCVA in the non-amblyopic eye of 0.1 logMAR or better, and an interocular VA difference of 2 logMAR lines or more
- +Difference of 1.00D or more between current refractive correction and study prescription
- +Good general health
Exclusion
- −Other pathological ocular anomalies known to cause reduced visual acuity
- −Presbyopia (based on amplitude of accommodation)
- −Inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia)
- −Contraindication to cycloplegic eye drops
- −Currently under amblyopia treatment/therapy
- −Inability to comprehend test instructions and/or provide consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Eccentric fixation
- −\>-6.00DS of myopia in either eye with spectacles
- −Bilateral amblyopia
- −Presence of amblyopia that is not due to strabismus and/or anisometropia
- −Presence of (current or previous) psychiatric, visual, or neurological disorders
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Spectacles.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 39 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 36 people.
The study is currently expected to finish around May 2027.
The main measurement is taken over: Approx. 5 mins, baselineBaselineYour starting measurements, taken before treatment begins.Read more → (day 1 of spectacle wear).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Best corrected visual acuity of the amblyopic eye pre-intervention — measured over Approx. 5 mins, baselineBaselineYour starting measurements, taken before treatment begins.Read more → (day 1 of spectacle wear).
Best corrected visual acuity of the amblyopic eye post-intervention — measured over Approx. 5 mins, on completion of study (week 24).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05394987 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SpectaclesDevice
Prescription of refractive error correction in spectacles. Refractive error to be determined as part of standard optometric eye exam (performed by registered optometrist). Guidelines for optical correction for the prescription of the study spectacles (based on Pediatric Eye Disease Investigator Group \[PEDIG\] amblyopia clinical trial protocols): Hypermetropia: not undercorrected by \>+1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. Anisometropia: full correction of the anisometropic difference. Astigmatism: cylinder power in each eye should be within ≤±0.50D of fully correcting the astigmatism for each eye. If cylinder power is ≥1.00D, the prescribed axis in both eyes should be within ≤±6 deg of the cycloplegic refraction axis. Appropriate refractive error correction will be prescribed. Participants will be instructed to wear the optical correction full-time (i.e., \>50% of waking hours) for the duration of the study.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 39 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 39 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approx. 5 mins, baselineBaselineYour starting measurements, taken before treatment begins.Read more → (day 1 of spectacle wear).
The study as a whole is currently expected to finish around 2027-05-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 36 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Waterloo, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. Amblyopia causes reduced visual acuity in the absence of a pathology. Adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. However, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. This study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. Functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. This study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.