💬In plain words
What the trial is, and whether it could suit you
Intermittent Exotropia (IXT) is a common type of eye misalignment where one eye periodically turns outward, and control is typically much worse when looking at objects far away than close up. However, most currently available training programme are focused on near-viewing tasks. The goal of this clinical trial is to investigate if a new, structured, home-based near eye training program works to improve distance eye alignment control in children and young adults with IXT.
The main questions the study aims to answer are:
* Does a 12-week near eye training program improve a participant's ability to control their eye alignment when looking at a distance?
* Does using a special reading glasses during near training help to control distance eye alignment better than doing the training without the reading glasses?
* Do the benefits of this eye training last after the training has stopped?
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📋 Eligibility rules (as published)
Inclusion Criteria
* Age and Diagnosis: Participants must be aged 6 to ≤ 25 years at the time of screening, with a confirmed clinical diagnosis of either Basic or Divergence Excess (DE) Intermittent Exotropia (IXT).
* Ocular Alignment Magnitude: Distance exodeviation measuring between 10 and 40 prism diopters (pd) inclusive, determined by the prism and alternate cover test (PACT).
* Distance-Near Disparity Limits: Near exodeviation must not exceed the distance exodeviation by more than 10 pd (to exclude Convergence Insufficiency type exotropia).
* Baseline Distance Control: A baseline distance IXT Office Control Score (OCS) between Grade 2 and Grade 4 inclusive, based on the mean of 3 standardized assessments.
* Baseline Near Control: A baseline near IXT control score less than or equal to the distance IXT control score, based on the mean of 3 standardized assessments.
* Visual Acuity: Best-corrected visual acuity (BCVA) of Logarithm of the Minimum Angle of Resolution (logMAR) 0.1 or better in each eye at both distance and near fixation.
* Sensory Status: Measurable near stereoacuity of 400 arc seconds or better on the Preschool Randot stereoacuity test.
* Refractive Correction Stability: Compliance with wearing a stable, appropriate spectacle correction for ≥ 4 months prior to formal baseline assessment if the participant meets any of the following refractive thresholds:
* Myopia \< -0.50D spherical equivalent (SE) in either eye.
* Hyperopia \> +2.50D SE in either eye.
* Anisometropia \> 1.00 SE.
* Astigmatism \> 1.50D cylinder in either eye.
* Treatment History: No history of prior non-surgical interventions for IXT, including patching, vision therapy/orthoptics, or overminus lens therapy (≥ 0.50 D).
* Surgical History: No prior history of strabismus surgery, extraocular muscle botulinum toxin injections, intraocular surgery, or refractive surgery.
* Trial Commitment: No planned strabismus surgery or conflicting ocular therapies during the 24-week study period.
Exclusion Criteria
* Amblyopia and Co-morbid Strabismus: Presence of amblyopia, nystagmus, restrictive strabismus, or paretic strabismus.
* Vertical Misalignment: Presence of an associated vertical ocular deviation \> 5 pd.
* Significant Pathologies: Co-existing significant ocular disease or neurological disorders (e.g., cerebral palsy) that could confound oculomotor or sensory evaluations.
* Confounding Medications: Regular use of systemic or topical ocular medications known to alter accommodative or vergence function within the 3 months prior to screening (including, but not limited to, atropine, pirenzepine, or systemic anti-epileptic agents).
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