ClinicalTrials.gg
Not yet recruitingNCT07563959ViT(I)SUpdated May 4, 2026

Visual Therapy for Intermittent Strabismus

An interventional study of Visual Therapy in Intermittent Strabismus, Exotropia Intermittent and Esotropia Intermittent, sponsored by Universitat Politècnica de Catalunya. Not yet recruiting. Open to participants aged 8 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Universitat Politècnica de Catalunya · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
8 Years to 50 Years
Sex
All
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Study summary

Intermittent strabismus is a condition in which the eyes occasionally become misaligned, affecting binocular vision, depth perception, and quality of life. Standard treatment often involves surgery of the eye muscles, although its effectiveness and timing remain debated.

Visual therapy is a non-invasive alternative that uses structured exercises to improve eye coordination and binocular vision. However, there is limited high-quality evidence supporting its effectiveness in intermittent strabismus.

This randomized controlled trial aims to evaluate whether a 12-session visual therapy program improves eye alignment, binocular vision, control of strabismus, and quality of life in individuals aged 8 to 50 years with intermittent horizontal strabismus.

Participants will be assigned to either a visual therapy group or a control group without treatment. Visual therapy will include weekly in-office sessions combined with short daily home exercises.

The study will assess changes before and after the intervention to determine whether visual therapy is an effective, non-invasive treatment option that could reduce the need for surgery.

Read the detailed description

Strabismus is a heterogeneous condition that may arise from alterations in extraocular muscles, their innervation, or central nervous system mechanisms. In this study, strabismus refers specifically to intermittent horizontal strabismus not associated with ocular, systemic, or neurological pathology, nor with orbital or craniofacial abnormalities.

Surgical correction of extraocular muscles is currently the main treatment approach. However, controversy exists regarding surgical indications, timing, and long-term outcomes. Furthermore, growing evidence suggests that many cases of strabismus may be related to central nervous system dysfunction rather than primary muscular abnormalities.

Visual therapy (VT) is a non-invasive intervention consisting of structured exercises designed to improve oculomotor control and enhance sensory and motor fusion. Neuroimaging studies have demonstrated central nervous system changes following VT in conditions such as convergence insufficiency, supporting its potential mechanism of action.

Despite these findings, evidence supporting VT for intermittent strabismus remains limited and is primarily based on case series and retrospective studies. Therefore, a prospective, randomized controlled trial is needed.

This study is a single-center, prospective, randomized, controlled, single-masked clinical trial conducted at Hospital Universitari Mútua de Terrassa.

Participants aged 8 to 50 years with intermittent horizontal strabismus will be recruited and randomly assigned to:

Experimental group: visual therapy Control group: no treatment during the study period

The intervention will consist of 12 weekly in-office sessions (1 hour each) at the Centre Universitari de la Visió, combined with daily home-based exercises (\~10 minutes), with adherence monitoring.

Outcome assessments will be conducted at baseline (T0) and post-treatment (T1) using standardized optometric procedures. Outcome assessors will be masked to group allocation to minimize bias.

Primary outcomes include changes in ocular deviation measured using alternate cover test with prism bars and Hirschberg test. Secondary outcomes include binocular function (fusion and stereopsis), control of deviation (Mohney and Holmes Office Control Score), and vision-related quality of life (AS-20 for adults and IXTQ for children).

Statistical analysis will compare pre- and post-intervention changes between groups using repeated measures models or equivalent non-parametric tests where appropriate.

The intervention poses minimal risk, as it is non-invasive and does not involve pharmacological treatment. Potential risks are limited to mild visual fatigue or unmet expectations, which will be mitigated through appropriate participant information.

This study aims to determine whether visual therapy can serve as an effective, non-invasive treatment for intermittent strabismus and potentially reduce the need for surgical intervention.

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Conditions studied

  • Intermittent Strabismus
  • Exotropia Intermittent
  • Esotropia Intermittent

Keywords

  • Intermittent Strabismus
  • Visual Therapy
  • Binocular Vision
  • Exotropia
  • Esotropia
  • Pediatric and Adult Strabismus
  • Quality of Life
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In context

Esotropia

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

This study's planned enrollment of 30 is below the median of 78 across 23 interventional studies indexed under Esotropia.

Browse Esotropia studies →

Lead sponsor

Universitat Politècnica de Catalunya is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
8 Years to 50 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

Individuals aged 8 to 50 years Diagnosis of intermittent horizontal strabismus (exotropia or esotropia) Absence of associated ocular, systemic, or neurological pathology Ability to understand and follow study instructions Willingness and motivation to complete 12 sessions of visual therapy (for the experimental group) Written (and assent for minors when applicable)

Exclusion criteria

Exclusion Criteria:

Previous visual therapy treatment Inability to attend in-office visual therapy sessions Presence of ocular, systemic, or neurological disease affecting vision Constant strabismus Cognitive or intellectual impairment limiting the ability to perform the exercises

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

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

Study arms

  • Experimental
    Visual Therapy

    Participants will receive a structured visual therapy program consisting of 12 weekly in-office sessions (1 hour each) combined with daily home-based exercises (\~10 minutes), with adherence monitoring.

    Behavioral: Visual Therapy

  • No intervention
    Control

    Participants will not receive any intervention during the study period. They will undergo the same baseline and post-study assessments as the experimental group.

Interventions

  • BehavioralVisual Therapy

    A structured program of visual exercises designed to improve oculomotor control and binocular vision. The intervention includes 12 weekly in-office sessions (1 hour each) conducted at a specialized center, combined with daily home-based exercises (\~10 minutes), with adherence monitoring.

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What researchers measure

Primary outcomes

  1. Change in Ocular Deviation

    Ocular deviation will be assessed using the alternate cover test with prism bars in primary gaze and Hirschberg test with image capture. The magnitude of deviation will be expressed in prism diopters (PD).

    Time frame: Baseline (T0) to 12 weeks (T1)

  2. Change in Binocular Function (Fusion and Stereopsis)

    Binocular function will be assessed using the Worth 4 Dot test (fusion) and stereopsis tests at near distance.

    Time frame: Baseline (T0) to 12 weeks (T1)

  3. Change in Strabismus Control

    Control of strabismus will be assessed using the Mohney and Holmes Office Control Score, a 5-point ordinal scale evaluating the frequency and control of ocular deviation.

    Time frame: Baseline (T0) to 12 weeks (T1)

  4. Change in Vision-Related Quality of Life

    Quality of life will be assessed using validated questionnaires: AS-20 for adults and Intermittent Exotropia Questionnaire (IXTQ) for pediatric participants.

    Time frame: Baseline (T0) to 12 weeks (T1)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Sunyer-Grau B, Quevedo L, Rodriguez-Vallejo M, Argiles M. Comitant strabismus etiology: extraocular muscle integrity and central nervous system involvement-a narrative review. Graefes Arch Clin Exp Ophthalmol. 2023 Jul;261(7):1781-1792. doi: 10.1007/s00417-022-05935-9. Epub 2023 Jan 21. PubMed 36680614 ↗
  • Sunyer-Grau B, Quevedo L, Rodriguez-Vallejo M, Argiles M. Surgical outcomes and etiological considerations in intermittent exotropia: a systematic narrative review. Strabismus. 2025 Sep;33(3):188-198. doi: 10.1080/09273972.2024.2449563. Epub 2025 Jan 7. PubMed 39773345 ↗
  • Ma MM, Kang Y, Chen C, Su C, Tian Z, Le M. Vision therapy for intermittent exotropia: A case series. J Optom. 2021 Jul-Sep;14(3):247-253. doi: 10.1016/j.optom.2020.05.006. Epub 2020 Aug 12. PubMed 32800454 ↗
  • Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4. PubMed 34516656 ↗
  • Alvarez TL, Vicci VR, Alkan Y, Kim EH, Gohel S, Barrett AM, Chiaravalloti N, Biswal BB. Vision therapy in adults with convergence insufficiency: clinical and functional magnetic resonance imaging measures. Optom Vis Sci. 2010 Dec;87(12):E985-1002. doi: 10.1097/OPX.0b013e3181fef1aa. PubMed 21057347 ↗
  • Bui Quoc E, Milleret C. Origins of strabismus and loss of binocular vision. Front Integr Neurosci. 2014 Sep 25;8:71. doi: 10.3389/fnint.2014.00071. eCollection 2014. PubMed 25309358 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Jul 2028, 26 months later.

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

Registered
Apr 26, 2026
First posted
May 4, 2026
StartEst.
May 1, 2026
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jul 1, 2028
Last update
May 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 May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07563959
Lead sponsor
Universitat Politècnica de Catalunya
Collaborators
Hospital Universitari Mútua de Terrassa
Responsible party
Laura Asensio Jurado (PhD, Universitat Politècnica de Catalunya) — Principal investigator
First posted
May 4, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
May 4, 2026

Study contacts

Laura Asensio Jurado, PhD
Contact
asensiojlaura@upc.edu
0034636760450

Oversight

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 Apr 2026. You cannot join it, but the record below documents what was studied.

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