Clinical Treatment of Transcranial Direct Current Stimulation in Older Adolescents With Amblyopia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Amblyopia

In brief

As a neurodevelopmental visual disorder, amblyopia, especially monocular form-deprivation amblyopia, can lead to severe visual developmental impairments. Due to reduced neural plasticity in the visual cortex after the critical period of visual development, older children and adults with amblyopia show poor responses to conventional treatments, lacking effective therapeutic options. Recent basic and clinical research has shown that transcranial direct current stimulation can effectively treat adult amblyopia by altering cortical excitability, enhancing synaptic plasticity, and affecting the excitatory/inhibitory balance in the cortex to reboot adult visual cortex plasticity. This proposed study aims to conduct a large-scale prospective randomized controlled trial to objectively assess the efficacy and safety of transcranial direct current stimulation in treating amblyopia in older adolescents and adults. By comparing changes in best-corrected visual acuity, visual evoked potentials(VEPs), contrast sensitivity, and functional connectivity between the visual cortex and other cortical areas using fMRI, the study seeks to provide robust clinical evidence, clarify the treatment effects of transcranial direct current stimulation in adult amblyopia, elucidate potential mechanisms of enhancing adult visual cortex plasticity with transcranial direct current stimulation, and potentially offer a safe and effective treatment modality for adult amblyopia.

Key facts

Study ID

NCT06760910

Run by

Tianjin Eye Hospital

People needed

40

Starts

2021-01-30

Expected to finish

2026-12-30

Last updated by the study team

2025-01-07

Who can join

Age: 10 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Tianjin Eye Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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