Actively Recruiting
Transcranial Direct Current Stimulation for Treating Amblyopia in Older Adolescents and Young Adults: A Prospective Cohort Study
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
Amblyopia, a neurodevelopmental visual disorder, particularly the monocular form-deprivation type, can cause serious vision problems. Older children and adults with amblyopia often respond poorly to traditional treatments due to reduced brain plasticity after the critical development period. Recent studies suggest that transcranial direct current stimulation (tDCS) may improve adult amblyopia by enhancing brain plasticity and adjusting the balance of brain activity. This study aims to conduct a large, prospective randomized controlled trial to evaluate the safety and effectiveness of tDCS in treating amblyopia in older adolescents and adults, while exploring underlying brain mechanisms using brain imaging and other tests. Participants will be divided into two groups: one receiving anodal tDCS applied over the occipital cortex at 0.1 mA for 20 minutes twice a week for six months, and the other receiving sham (placebo) stimulation with similar setup but no current. Brain imaging using resting-state and task-based functional MRI will be performed before and after treatment to assess changes in brain activity and connectivity related to visual processing. This design helps to determine the impact of tDCS on brain plasticity and vision improvement. During the study, participants will undergo visual acuity evaluations, visual evoked potentials, contrast sensitivity tests, and functional brain scans to measure changes in vision and brain function. Researchers will monitor adherence and safety throughout the six-month treatment period. The primary outcome is improvement in best-corrected visual acuity after 24 weeks. This trial offers a structured approach to assess tDCS as a potential treatment option for amblyopia in older adolescents and adults, with follow-up assessments to understand treatment effects and brain changes.
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
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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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