Visual Therapy for Intermittent Strabismus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-50
SponsorUniversitat Politècnica de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Visual Therapy
BehavioralA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Visual TherapyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat Politècnica de Catalunya
Lead sponsor
Hospital Universitari Mútua de Terrassa
Collaborator
Source ClinicalTrials.gov
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