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New treatment option for Intermittent Exotropia
Official title Near Vergence Training for Distance Control in Intermittent Exotropia
ClinicalTrials.gov ID: NCT07642687
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 25
You may be able to join if
- 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...
- Ocular Alignment Magnitude: Distance exodeviation measuring between 10 and 40 prism diopters (pd) inclusive, determined by the prism and alternate...
- Distance-Near Disparity Limits: Near exodeviation must not exceed the distance exodeviation by more than 10 pd (to exclude Convergence Insufficiency...
- Baseline Distance Control: A baseline distance IXT Office Control Score (OCS) between Grade 2 and Grade 4 inclusive, based on the mean of 3...
- 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...
You likely can't join if
- 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...
- Confounding Medications: Regular use of systemic or topical ocular medications known to alter accommodative or vergence function within the 3 months...
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.