Actively Recruiting

Phase Not Applicable
Age: 10Years - 30Years
All Genders
Healthy Volunteers
NCT06760910

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

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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

Age: 10Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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