RecruitingNot ApplicableNCT06760910

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

Efficacy of Transcranial Direct Current Stimulation in the Amblyopia Treatment of Older Adolescents: A Cohort Study


Sponsor

Tianjin Eye Hospital

Enrollment

40 participants

Start Date

Jan 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 10 YearsMax Age: 30 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

PROCEDUREtDCS Stimulation

Anode tDCS or sham stimulation for amblyopia of Adolescents

DEVICEAnodal tDCS

Anodal tDCS

DEVICESham tDCS

Sham tDCS


Locations(1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

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NCT06760910


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