Actively Recruiting
Clinical Treatment of Transcranial Direct Current Stimulation in Older Adolescents With Amblyopia
Led by Tianjin Eye Hospital · Updated on 2025-01-07
40
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Treatment of Transcranial Direct Current Stimulation in Older Adolescents With Amblyopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and their legal guardians have provided written consent.
- Participants are aged 10 to 30 years, any gender.
- Participants meet amblyopia diagnosis: unilateral amblyopia with two or more lines difference in visual acuity between eyes, or bilateral amblyopia with best-corrected visual acuity worse than 20/30 (0.2 logMAR) using LEA SYMBOLS4 or HOTV visual acuity charts.
You will not qualify if you...
- Eye diseases affecting vision or refractive errors such as cataracts, lens damage, glaucoma, macular degeneration, corneal disorders, retinitis pigmentosa, retinal detachment, or severe vitreous opacities.
- History of eye trauma or intraocular surgery.
- Inability to cooperate with examinations.
- Presence of systemic diseases like epilepsy.
- Participation in any other experimental treatment within the past 3 months.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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