ClinicalTrials.gg
RecruitingNCT06622044Updated Sep 4, 2026

Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia

An interventional study of Vision therapy group and Prism in Esotropia, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 10 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

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

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Esotropia

Browse trials for

Keywords

  • Vision Therapy
  • Acute Acquired Concomitant Esotropia
03

In context

Esotropia

36 studies on the registry are indexed under Esotropia; 11 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 23 interventional studies indexed under Esotropia.

Browse Esotropia 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
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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. Aged 10-40 years (including 10 years and 40 years);
  2. Best-corrected visual acuity no worse than 20/20 for both eyes;
  3. Deviation angle less than 15 prism diopters (including 15 prism diopters);

Exclusion criteria

Exclusion Criteria:

  1. Organic eye diseases;
  2. Lesions of the brain;
  3. Receiving esotropia therapy(including surgery and prism treatment)
  4. Devation angle reducing more than 10 prism diopters after refractive correction
05

Study design

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

Study arms

  • Experimental
    Vision therapy group

    Accommodation facility exercises and divergence exercises

    Other: Vision therapy group

  • Active comparator
    Prism group

    wearing prism glasses

    Other: Prism

Interventions

  • OtherVision therapy group

    accommodation and vergence exercise

  • OtherPrism

    wearing prism glasses

06

What researchers measure

Primary outcomes

  1. Change in deviation angle at distance and near

    the deviation angle measured using the alternate prism cover test

    Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks

Secondary outcomes

  1. Changes in stereopsis

    Near and far stereopsis measured with Randot Stereotest pattern

    Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks

  2. Changes in accommodation facility

    Accommodation facility measured with accommodative flipper

    Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks

  3. Changes in accommodation function

    Accommodation function including accommodation amplitude, accommodation response, positive relarive accommodation, and negative relative accommodation measured with phoropter

    Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks

  4. Change in accommodation convergence to accommodation(AC/A) ratio

    AC/A ratio measured with synoptophore

    Time frame: 1 weeks, 4weeks, 12 weeks, 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2024
First posted
Oct 1, 2024
StartActual
Sep 7, 2024
Primary completionEst.
Sep 7, 2026
CompletionEst.
Dec 7, 2026
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06622044
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Sep 7, 2024
Primary completion
Sep 7, 2026 (estimated)
Completion
Dec 7, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Wen Wen, MD, PhD
Contact
wenweneye@126.com
+86 (21) 3423 3133
Shuyang Guo, MD
Contact
m15880091363@163.com

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion