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.
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.
Shuyang Guo, MD contact
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, China
Wen Wen, MD, PhD, 86+(021)34233133, wenweneye@126.com
Wen Wen, MD, PhD
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.
- Conditions
- Presbyopia, Esotropia
- 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 group | Role | What they receive |
|---|---|---|
| Transcranial Electrical Stimulation Group | Experimental | visual training combined with transcranial electrical stimulation Receives: Device: Transcranial Electrical Stimulation |
| Visual Training Group | Active comparator | visual training Receives: Other: Visual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Accommodation Response
using binocular cross-cylinder method to evaluate accommodation response
Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
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
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.
- First posted4 Dec 2024
- Study start31 Dec 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Wen, MD, PhD, Study chair, Eye & ENT Hospital of Fudan University, Shanghai, China
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06714890
- Acronym / sponsor ID
- 2024-tES
- Conditions
- Presbyopia, Esotropia
- Keywords
- Acute Acquired Concomitant Esotropia, Presbyopia, Accommodation Disorder, Transcranial Electrical Stimulation, Visual Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Electrical Stimulation Group | Experimental | Device: Transcranial Electrical Stimulationvisual training combined with transcranial electrical stimulation |
| Visual Training Group | Active comparator | Other: Visual Trainingvisual training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Electrical StimulationTranscranial Electrical Stimulation Combined with Accommodation-related Visual Training | Device | Transcranial Electrical Stimulation Group |
| Visual TrainingAccommodation-related Visual Training | Other | Visual Training Group |
Primary outcome
Amplitude of Accommodation
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
using minus lens method to evaluate amplitude of accommodation
Accommodation Response
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
using binocular cross-cylinder method to evaluate accommodation response
Positive and negative relative accommodation
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
using phoropter examination to evaluate positive and negative relative accommodation
Accommodation Facility
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Using flipper to evaluate the accommodation facility
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it iss better to protect the publication potential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuyang Guo, MD contact
Wen Wen, MD, PhD study chair
Eye & ENT Hospital of Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
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.