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PresbyopiaNCT06714890

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

A study testing Transcranial Electrical Stimulation and Visual Training in people with Presbyopia and Esotropia, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Presbyopia, Esotropia
What is being tested?
Transcranial Electrical Stimulation and Visual Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
31 Dec 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
  • Inclusion criteria for presbyopia: clinical diagnosis of presbyopia; best corrected visual acuity of both eyes ≥ 1.0.

Who cannot join

  • no history of other eye diseases or eye surgeries
  • no history of neuropsychiatric diseases for the individual or relatives
  • no head injuries or surgeries
  • no history of epilepsy or stroke
  • no metal implants in the body
  • no claustrophobia, no metal implants in the body (fracture fixation nails, pacemakers, etc.)
  • pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wen Wen, MD, PhD contact

+86 (21) 3423 3133

wenweneye@126.com

Shuyang Guo, MD contact

m15880091363@163.com

China1 site
  • Eye & ENT Hospital of Fudan University

    Shanghai, China

    Wen Wen, MD, PhD, 86+(021)34233133, wenweneye@126.com

    Wen Wen, MD, PhD

Other trials in China

About this study

Official title: A Single-center, Prospective, Randomized Controlled Trial Evaluating Accommodation-related Visual Training Combined with Transcranial Electrical Stimulation Versus Accommodation-related Visual Training Alone for the Treatment of Accommodation Dysfunction

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.

Being tested
Transcranial Electrical Stimulation, Visual Training
Keywords
Acute Acquired Concomitant Esotropia, Presbyopia, Accommodation Disorder, Transcranial Electrical Stimulation, Visual Training
Medical subject headings
Presbyopia, Esotropia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Electrical StimulationDevice

    Transcranial Electrical Stimulation Combined with Accommodation-related Visual Training

  • Visual TrainingOther

    Accommodation-related Visual Training

Study groups in NCT06714890
Study groupRoleWhat they receive
Transcranial Electrical Stimulation GroupExperimentalvisual training combined with transcranial electrical stimulation
Receives: Device: Transcranial Electrical Stimulation
Visual Training GroupActive comparatorvisual training
Receives: Other: Visual Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amplitude of Accommodation

    using minus lens method to evaluate amplitude of accommodation

    Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

  2. Accommodation Response

    using binocular cross-cylinder method to evaluate accommodation response

    Measured: 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

    Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

  4. Accommodation Facility

    Using flipper to evaluate the accommodation facility

    Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start31 Dec 2024 (estimated)
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714890
Sponsor's protocol ID
2024-tES
Status last verified
Dec 2024
First submitted
2 Dec 2024
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We concerns about patient privacy issues and it iss better to protect the publication potential.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Electrical Stimulation and Visual Training in people with Presbyopia and Esotropia, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen Wen, MD, PhD (+86 (21) 3423 3133, wenweneye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude of Accommodation (time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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