EsotropiaNCT06622044
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
A study testing Vision therapy group and Prism in people with Esotropia, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This prospective, single-center, nonrandomized comparative study evaluates 6-month ocular alignment and binocular visual function outcomes following combined accommodation and fusional training or prism correction in patients with small-angle acute acquired comitant esotropia. Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Esotropia
- What is being tested?
- Vision therapy group and Prism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2024to 7 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 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 10-40 years (including 10 years and 40 years);
- Best-corrected visual acuity no worse than 20/20 for both eyes;
- Deviation angle less than 15 prism diopters (including 15 prism diopters);
Who cannot join
- Organic eye diseases;
- Lesions of the brain;
- Receiving esotropia therapy(including surgery and prism treatment)
- Devation angle reducing more than 10 prism diopters after refractive correction
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, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, China
About this study
Official title: Accommodation and Vergence Exercises Versus Prism Treatment for Small-angle Acute Acquired Concomitant Esotropia
This prospective, single-center, nonrandomized comparative study evaluates 6-month ocular alignment and binocular visual function outcomes following combined accommodation and fusional training or prism correction in patients with small-angle acute acquired comitant esotropia. Treatment was selected through shared decision-making between the patient and the treating clinician according to the clinical presentation and patient preference.
Read the detailed description
Acute acquired concomitant esotropia (AACE) belongs to the category of concomitant strabismus. It is characterized by sudden onset, often accompanied by diplopia, and no change in the strabismus angle of each eye position. In recent years, with the increase in the use of smartphones and other screen devices, the incidence of AACE has been on the rise. Commonly used treatments in clinical practice include surgical treatment, botulinum toxin injection into the medial rectus muscle, and prism treatment. Patients with large-angle esotropia generally require surgical intervention to fundamentally correct patients eye positions and eliminate diplopia. However, surgical treatment requires waiting for six months in order to performed after the strabismus degree is stable. There are also risks of intraoperative trauma and secondary surgery. Patients with early and small-angle esotropia often choose prism treatment.
The principle of prism treatment is light refraction. After light is refracted through a prism, it falls on the fovea of the strabismic eye, eliminating diplopia. In the treatment of AACE, the main target population of prisms is patients with mild strabismus (the strabismus angle is usually less than 25 PD). Wearing prisms can eliminate diplopia and relieve related symptoms, but it does not really correct the strabismus problem.
The high incidence of AACE is related to excessive close work and use of electronic products. Excessive close eye use can lead to accommodative dysfunction. Studies have found that AACE patients have abnormal accommodative function. The accommodative function of AACE patients is weaker than normal, and the accommodation convergence to accommodation (AC/A) ratio is higher than normal. During clinical diagnosis and treatment, the accommodative function of AACE patients was examined and it was found that there was indeed abnormal accommodative function. Based on scientific research findings and the actual basis of clinical practice, improving accommodative function through accommodative training may be a good treatment option for early and small-angle AACE patients. However, existing studies have not fully explored the effectiveness and safety of accommodative exercise in the treatment of small-angle AACE, and there has been no study comparing the therapeutic outcomes of accommodative training and prism treatment on small-angle AACE.
In order to better guide clinical practice, we conducted a prospective, single-center, nonrandomized comparative study to objectively evaluate and compare the therapeutic effects of accommodative training and prism therapy on AACE. It is expected that the research results will provide more treatment options for AACE patients and provide important guidance for clinical selection of appropriate methods to treat small-angle AACE.
- Conditions
- Esotropia
- Being tested
- Vision therapy group, Prism
- Keywords
- Vision Therapy, Acute Acquired Concomitant Esotropia
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision therapy groupOther
accommodation and vergence exercise
PrismOther
wearing prism glasses
| Study group | Role | What they receive |
|---|---|---|
| Vision therapy group | Experimental | Accommodation facility exercises and divergence exercises Receives: Other: Vision therapy group |
| Prism group | Active comparator | wearing prism glasses Receives: Other: Prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in deviation angle at distance and near
the deviation angle measured using the alternate prism cover test
Measured: 1 weeks, 4weeks, 12 weeks, 24 weeks
Secondary outcomes (4)
Changes in stereopsis
Near and far stereopsis measured with Randot Stereotest pattern
Measured: 1 weeks, 4weeks, 12 weeks, 24 weeks
Changes in accommodation facility
Accommodation facility measured with accommodative flipper
Measured: 1 weeks, 4weeks, 12 weeks, 24 weeks
Changes in accommodation function
Accommodation function including accommodation amplitude, accommodation response, positive relarive accommodation, and negative relative accommodation measured with phoropter
Measured: 1 weeks, 4weeks, 12 weeks, 24 weeks
Change in accommodation convergence to accommodation(AC/A) ratio
AC/A ratio measured with synoptophore
Measured: 1 weeks, 4weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start7 Sep 2024
- Primary completion7 Sep 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsotropiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Non-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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622044
- Sponsor's protocol ID
- 2024-ATAACE
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We concerns about patient privacy issues and it\'s better to protect the publication potential.
Publications
Guo S, Ling L, Ding Z, Liu J, Liu Y, Liu R, Chen Z, Zhao C, Xi S, Wen W. Combined Accommodation and Fusional Training Paradigm Versus Prism Correction for Small-Angle Acute Acquired Comitant Esotropia: A Cohort Study. Ophthalmol Ther. 2026 Oct 3. doi: 10.1007/s40123-026-01507-w. Online ahead of print.
PubMed 42828678
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accommodation and Vergence Exercises Versus Prism Treatment for Small-angle Acute Acquired Concomitant Esotropia
- ClinicalTrials.gov ID
- NCT06622044
- Acronym / sponsor ID
- 2024-ATAACE
- Conditions
- Esotropia
- Keywords
- Vision Therapy, Acute Acquired Concomitant Esotropia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 1 Oct 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 prospective, single-center, nonrandomized comparative study evaluates 6-month ocular alignment and binocular visual function outcomes following combined accommodation and fusional training or prism correction in patients with small-angle acute acquired comitant esotropia. Treatment was selected through shared decision-making between the patient and the treating clinician according to the clinical presentation and patient preference.
Detailed description
Acute acquired concomitant esotropia (AACE) belongs to the category of concomitant strabismus. It is characterized by sudden onset, often accompanied by diplopia, and no change in the strabismus angle of each eye position. In recent years, with the increase in the use of smartphones and other screen devices, the incidence of AACE has been on the rise. Commonly used treatments in clinical practice include surgical treatment, botulinum toxin injection into the medial rectus muscle, and prism treatment. Patients with large-angle esotropia generally require surgical intervention to fundamentally correct patients eye positions and eliminate diplopia. However, surgical treatment requires waiting for six months in order to performed after the strabismus degree is stable. There are also risks of intraoperative trauma and secondary surgery. Patients with early and small-angle esotropia often choose prism treatment.
The principle of prism treatment is light refraction. After light is refracted through a prism, it falls on the fovea of the strabismic eye, eliminating diplopia. In the treatment of AACE, the main target population of prisms is patients with mild strabismus (the strabismus angle is usually less than 25 PD). Wearing prisms can eliminate diplopia and relieve related symptoms, but it does not really correct the strabismus problem.
The high incidence of AACE is related to excessive close work and use of electronic products. Excessive close eye use can lead to accommodative dysfunction. Studies have found that AACE patients have abnormal accommodative function. The accommodative function of AACE patients is weaker than normal, and the accommodation convergence to accommodation (AC/A) ratio is higher than normal. During clinical diagnosis and treatment, the accommodative function of AACE patients was examined and it was found that there was indeed abnormal accommodative function. Based on scientific research findings and the actual basis of clinical practice, improving accommodative function through accommodative training may be a good treatment option for early and small-angle AACE patients. However, existing studies have not fully explored the effectiveness and safety of accommodative exercise in the treatment of small-angle AACE, and there has been no study comparing the therapeutic outcomes of accommodative training and prism treatment on small-angle AACE.
In order to better guide clinical practice, we conducted a prospective, single-center, nonrandomized comparative study to objectively evaluate and compare the therapeutic effects of accommodative training and prism therapy on AACE. It is expected that the research results will provide more treatment options for AACE patients and provide important guidance for clinical selection of appropriate methods to treat small-angle AACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vision therapy group | Experimental | Other: Vision therapy groupAccommodation facility exercises and divergence exercises |
| Prism group | Active comparator | Other: Prismwearing prism glasses |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 10-40 years (including 10 years and 40 years);
- Best-corrected visual acuity no worse than 20/20 for both eyes;
- Deviation angle less than 15 prism diopters (including 15 prism diopters);
Key exclusion criteria (4 listed)
- Organic eye diseases;
- Lesions of the brain;
- Receiving esotropia therapy(including surgery and prism treatment)
- Devation angle reducing more than 10 prism diopters after refractive correction
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 |
|---|---|---|
| Vision therapy groupaccommodation and vergence exercise | Other | Vision therapy group |
| Prismwearing prism glasses | Other | Prism group |
Primary outcome
Change in deviation angle at distance and near
Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks
the deviation angle measured using the alternate prism cover test
4 secondary outcomes
Changes in stereopsis
Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks
Changes in accommodation facility
Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks
Changes in accommodation function
Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks
Change in accommodation convergence to accommodation(AC/A) ratio
Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks
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 4 Sep 2026.
- Derived from this study: PubMed 42828678Guo S, Ling L, Ding Z, Liu J, Liu Y, Liu R, Chen Z, Zhao C, Xi S, Wen W. Combined Accommodation and Fusional Training Paradigm Versus Prism Correction for Small-Angle Acute Acquired Comitant Esotropia: A Cohort Study. Ophthalmol Ther. 2026 Oct 3. doi: 10.1007/s40123-026-01507-w. Online ahead of print.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it\'s better to protect the publication potential.
Related trials for Esotropia
Active, not recruitingObservational study
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Congenital Esotropia
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Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
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Visual Therapy for Intermittent Strabismus
Intermittent Strabismus, Exotropia Intermittent
Not yet recruitingPhase 3
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
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Not yet recruiting
Risk Factors And Surgical Outcomes Of Strabismus Reoperation
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision therapy group and Prism in people with 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
Change in deviation angle at distance and near (time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622044, which also lists 1 linked publication.
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 4 Sep 2026.