Optical Correction and Visual Functions of Adults With Amblyopia (NCT05394987) | Clinical Trial Compass
RecruitingNot Applicable
Optical Correction and Visual Functions of Adults With Amblyopia
Canada, Hong Kong36 participantsStarted 2022-06-13
Plain-language summary
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.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 consent
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best corrected visual acuity of the amblyopic eye pre-intervention
Timeframe: Approx. 5 mins, baseline (day 1 of spectacle wear)
2
Best corrected visual acuity of the amblyopic eye post-intervention
Timeframe: Approx. 5 mins, on completion of study (week 24)