Treatment of amblyopia in older adolescents using brain stimulation
Efficacy of Transcranial Direct Current Stimulation in the Amblyopia Treatment of Older Adolescents: A Cohort Study
This study is testing if a brain stimulation treatment can help older teens and young adults with amblyopia see better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 10 Years to 30 Years |
| Sex | All |
| Sponsor | Tianjin Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06760910 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcranial direct current stimulation (tDCS) in improving visual outcomes for older adolescents with amblyopia. Participants aged 10-30 will be randomly assigned to receive either active tDCS or sham stimulation over a period of six months. The study will assess changes in visual acuity and brain activity using functional MRI before and after the treatment. The goal is to determine if tDCS can enhance visual cortex plasticity and improve vision in individuals with amblyopia.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-30 diagnosed with unilateral or bilateral amblyopia.
Not a fit: Patients with other eye diseases, significant refractive errors, or systemic conditions like epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for older adolescents suffering from amblyopia, potentially improving their visual acuity.
How similar studies have performed: Previous studies have shown promising results using tDCS for treating amblyopia in adults, suggesting potential efficacy in this age group as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and their legal guardians have obtained consent in writing. * Participants aged 10-30, of any gender. * Participants must meet the diagnostic criteria for amblyopia: unilateral amblyopia with a difference of two lines or more in visual acuity between the eyes, or bilateral amblyopia with best-corrected visual acuity worse than 20/30 (or worse than 0.2 logMAR). The visual acuity charts to be used are LEA SYMBOLS® (Good-Lite Co., Elgin, IL) or HOTV visual acuity chart. Exclusion Criteria: * Participants who may have eye diseases affecting vision or refractive errors (such as cataracts, crystalline lens damage, glaucoma, macular degeneration, corneal disorders, retinitis pigmentosa, retinal detachment, severe vitreous opacities, etc * History of eye trauma or intraocular surgery * Inability to cooperate with examinations * Presence of concomitant systemic diseases (such as epilepsy) * Participation in any other experimental treatment within the past 3 months * Other situations deemed unsuitable by the investigator.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.