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Clinical Trials/NCT05016830
NCT05016830
Terminated
N/A

Effect of the Combination of tDCS and Visual Occlusion Therapy on Visual Acuity, Contrast Vision and Depth Vision, in Adult Patients With Amblyopia

University of Chile1 site in 1 country12 target enrollmentNovember 5, 2019
ConditionsAmblyopia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amblyopia
Sponsor
University of Chile
Enrollment
12
Locations
1
Primary Endpoint
Stereopsis
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

A prospective interventional study is expected to be conducted, to test a possible new treatment for amblyopia (lazy eye syndrome). Bilateral transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation, which may help in visual function recovery of adult patients with amblyopia. This pilot study will test the feasibility of said therapy, along with the short term effects of bilateral tDCS in visual function.

Detailed Description

Theoretical Framework: Ocular occlusion treatment has been used classically and with excellent results for the treatment of amblyopia in those under 14 years of age, since in this period it has been seen that there is greater neuroplasticity, leaving little to do in the period of lower neuroplasticity, in young and adult patients with later diagnoses. Transcranial Direct Current Stimulation therapy is an emergent technique used in neurological diseases to increase neuroplasticity, by changing the resting potential of neurons. Our hypothesis is that the combination of tDCS and visual occlusion therapy is capable of increasing visual acuity, contrast sensitivity, and depth perception, in young people over 18 years of age. Methodology: The application of a double-blind, randomized clinical trial is proposed to evaluate the application of 2 different therapies: Occlusion with bilateral tDCS, and Occlusion with tDCS sham (sham). The study subjects will be randomly assigned to a group, and one session of stimulation will be performed. Data will be analyzed using Student's t test, or Mann-Whitney test, according to the normal or non-normal distribution of the sample, respectively. Also, the change over time of the variables will be measured using the Conditional Change Model. Expected Results: The investigators expect that visual acuity, contrast vision, and dichoptic vision in the Occlusion therapy group with bilateral tDCS will be significantly higher than the Occlusion therapy group with tDCS sham (sham).

Registry
clinicaltrials.gov
Start Date
November 5, 2019
End Date
January 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Principal Investigator
Principal Investigator

Romulo Antonio Fuentes Flores

Assistant Professor at Department of Neuroscience, and Director of Research at the Faculty of Medicine of University of Chile

University of Chile

Eligibility Criteria

Inclusion Criteria

  • Prior diagnosis of Amblyopia

Exclusion Criteria

  • Ophthalmologic disease other than amblyopia
  • Chronic pharmacological therapy
  • Implanted medical device
  • Neurologic disease or surgery history
  • History of an adverse reaction to tDCS
  • Pregnancy
  • Not able to give informed consent

Outcomes

Primary Outcomes

Stereopsis

Time Frame: 1-2 hours

the perception of depth produced by the reception in the brain of visual stimuli from both eyes in combination. Measured in degrees of arc.

Visual Acuity

Time Frame: 1-2 hours

Clarity or Sharpness in vision, measured in LogMar

Visual Sensitivity

Time Frame: 1-2 hours

The ability to perceive differences between an object and its background, measured in percentage of contrast sensitivity.

Visual evoked potentials

Time Frame: 1-2 hours

The electroencephalographic response from the primary visual cortex to a stimuli. Measured in millivolts (mV).

Study Sites (1)

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