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Not yet recruitingNCT06714890Updated Dec 5, 2024

Accommodation-Related Visual Training Combined with Transcranial Electrical Stimulation Versus Visual Training Alone for the Treatment of Accommodation Dysfunction

An interventional study of Transcranial Electrical Stimulation and Visual Training in Presbyopia and Esotropia, sponsored by Eye & ENT Hospital of Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

This is a single-center, randomized controlled trial to compare the effectiveness of transcranial electrical stimulation combined with visual training with visual training alone for the treatment of accommodation disorder patients.

Read the detailed description

Accommodation is a dynamic process in which the eyes focus on targets at different distances. When the human eye turns its gaze point from far to near, the lens, ciliary body, and suspensory ligament need to work in coordination to make the object clearly imaged on the retina. Clinically, the occurrence and development of many ophthalmic diseases are related to accommodative dysfunction. This study mainly focuses on two types of accommodative eye diseases, presbyopia and acute acquired concomitant esotropia (AACE).

More than 1 billion adults worldwide are affected by presbyopia, and some studies believe that the occurrence of presbyopia is mainly related to the decline of accommodative function. Accommodative visual training can improve the symptoms of presbyopia, but there are problems such as long treatment course, great impact on daily life, and poor patient compliance. AACE is another eye disease related to accommodative dysfunction. AACE is a relatively rare type of esotropia, but the incidence has shown a significant upward trend in recent years. Scholars believe that its high incidence is mainly related to the increased accommodative load when the eyes are used excessively at close range. Studies have found that AACE at the early stage of onset and at a small angle can reduce the degree of strabismus through visual training related to accommodation, but the recovery of accommodation function and strabismus will have a plateau period, and patients have poor compliance with training. Since the existing treatment for accommodation dysfunction, namely visual training, has problems such as long treatment course, great impact on daily life, and poor compliance, it is necessary to explore more effective alternative treatment methods with lower compliance requirements to better serve the needs of patients.

Electrical stimulation treatment is very safe and is a non-invasive treatment method. By placing electrodes on specific brain areas and applying weak currents to the scalp, the state of brain activity is changed. This method has been widely used in other mental disorders. At present, in the field of ophthalmology, some scholars have used transcranial electrical stimulation to treat patients with amblyopia and convergence insufficiency, and found that electrical stimulation can improve patients' contrast sensitivity, stereoscopic vision and convergence function. The above studies have proved the application prospects of transcranial electrical stimulation in visual diseases, which can be used to treat visual diseases by reshaping the functions related to the visual nerve. Regarding the accommodation function, some scholars have also found that transcranial electrical stimulation can affect the accommodation function of the eye lens by changing the excitability of the visual cortex. In addition, magnetic resonance imaging studies have found brain areas related to accommodation function, including the frontal eye movement area and occipital lobe, which can be used as sites for electrical stimulation. Therefore, for patients with abnormal accommodation function, transcranial electrical stimulation therapy may be a promising treatment method. It can not only reshape the function of accommodation-related nerves, but also has the advantages of short treatment course, low compliance requirements, and no impact on patients' daily life. It can also make up for the disadvantages of visual training.

When exploring the potential effects of electrical stimulation combined with visual training on patients with abnormal accommodation function, functional magnetic resonance imaging (fMRI) technology will play a key role. Accommodation is a cause of many eye diseases, and there is little exploration of the brain area of accommodation function. Existing research on accommodation function focuses on the physiological structural changes of the lens and ciliary muscle. Through fMRI research, we can explore the activity changes and remodeling of the accommodation-related visual pathways in patients with abnormal accommodation function after receiving tDCS in a more in-depth and intuitive way.

Based on scientific research findings, tES combined with visual tasks can reshape the accommodative function, but no studies have fully explored the effectiveness and safety of this method in treating patients with abnormal accommodative function, nor have studies compared the therapeutic effects of visual training and tES combined with visual tasks on patients with abnormal accommodative function. In order to better guide clinical practice, we plan to conduct a randomized controlled study to objectively evaluate and compare the therapeutic effects of visual training and transcranial electrical stimulation combined with visual tasks on patients with abnormal accommodative function, and to conduct in-depth research on the remodeling of brain areas related to accommodation through fMRI technology. It is expected that the research results will provide more treatment options for patients with abnormal accommodative function, and provide important guidance for the clinical selection of appropriate methods to treat patients with abnormal accommodative function.

02

Conditions studied

  • Presbyopia
  • Esotropia

Keywords

  • Acute Acquired Concomitant Esotropia
  • Presbyopia
  • Accommodation Disorder
  • Transcranial Electrical Stimulation
  • Visual Training
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 100 is above the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Inclusion criteria for small-angle acute concomitant esotropia: clinical diagnosis of acute aquired concomitant esotropia; strabismus angle ≤ 15PD; age 18 \< age \< 40; best corrected visual acuity of both eyes ≥ 1.0.
  2. Inclusion criteria for presbyopia: clinical diagnosis of presbyopia; best corrected visual acuity of both eyes ≥ 1.0.

Exclusion criteria

Exclusion Criteria:

  1. no history of other eye diseases or eye surgeries
  2. no history of neuropsychiatric diseases for the individual or relatives
  3. no head injuries or surgeries
  4. no history of epilepsy or stroke
  5. no metal implants in the body
  6. no claustrophobia, no metal implants in the body (fracture fixation nails, pacemakers, etc.)
  7. pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Transcranial Electrical Stimulation Group

    visual training combined with transcranial electrical stimulation

    Device: Transcranial Electrical Stimulation

  • Active comparator
    Visual Training Group

    visual training

    Other: Visual Training

Interventions

  • DeviceTranscranial Electrical Stimulation

    Transcranial Electrical Stimulation Combined with Accommodation-related Visual Training

  • OtherVisual Training

    Accommodation-related Visual Training

06

What researchers measure

Primary outcomes

  1. Amplitude of Accommodation

    using minus lens method to evaluate amplitude of accommodation

    Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

  2. Accommodation Response

    using binocular cross-cylinder method to evaluate accommodation response

    Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

  3. Positive and negative relative accommodation

    using phoropter examination to evaluate positive and negative relative accommodation

    Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

  4. Accommodation Facility

    Using flipper to evaluate the accommodation facility

    Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — We concerns about patient privacy issues and it iss better to protect the publication potential.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06714890
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Dec 31, 2024 (estimated)
Primary completion
Aug 30, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 5, 2024

Study contacts

Wen Wen, MD, PhD
Contact
wenweneye@126.com
+86 (21) 3423 3133
Shuyang Guo, MD
Contact
m15880091363@163.com
Wen Wen, MD, PhD
study chair · Eye & ENT Hospital of Fudan University, Shanghai, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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