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RECRUITING Not applicable ClinicalTrials.gov

Effectiveness of Osteopathy as an Adjunct to Optometric Vision Therapy in Vergence Disorders

Sponsor: Jordi Zaragoza • ClinicalTrials.gov ID: NCT07452679

Registry updated: 2026-10-13
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Description

Vergence disorders are common binocular vision conditions that can cause symptoms such as eyestrain, blurred vision, headaches, and difficulty maintaining clear vision during near tasks. These symptoms are particularly frequent in situations involving sustained near visual demand, such as prolonged use of digital devices, which is increasingly common in daily life. Optometric vision therapy is considered the reference treatment for vergence disorders. However, not all individuals respond in the same way, and some continue to experience symptoms despite appropriate treatment. For this reason, adjunct therapeutic approaches are being explored to improve clinical outcomes. The purpose of this study is to evaluate whether osteopathic manual therapy, when used as an adjunct to optometric vision therapy, provides additional benefits compared with vision therapy alone or vision therapy combined with a sham osteopathic intervention. This randomized, controlled, double-blind clinical trial will compare three parallel groups and will assess changes in vergence function, oculomotor performance measured by video-oculography, and symptom improvement related to vergence disorders.

Interventions

  • Optometric Vision Therapy (Behavioral)
    Structured optometric vision therapy program consisting of in-office and home-based visual exercises aimed at improving binocular vision and vergence function. The intervention is standardized across participants and delivered by qualified optometrists following a predefined protocol.
  • Osteopathic Manual Therapy (Behavioral)
    Standardized manual osteopathic intervention delivered as an adjunct to optometric vision therapy. The intervention consists of predefined manual techniques targeting somatic dysfunctions potentially related to binocular vision and vergence, applied according to a fixed protocol and session schedule. The intervention protocol is predefined and documented in detail to ensure consistency across participants.
  • Sham Osteopathic Intervention (Behavioral)
    Sham manual intervention designed to mimic the context, duration, and therapist-participant interaction of the osteopathic intervention without applying therapeutic osteopathic techniques. The procedure is standardized and intended to maintain participant blinding.

Eligibility criteria

Inclusion Criteria: * Adult workers (≥18 years) whose regular occupational duties involve screen-based work. * Presence of symptoms consistent with binocular vision dysfunction, defined as a Convergence Insufficiency Symptom Survey (CISS-V15) score ≥21 at baseline screening. Exclusion Criteria: * Severe ocular disease or systemic conditions affecting vision (e.g., age-related macular degeneration, retinopathies, glaucoma, keratoconus). * Neurological disorders affecting ocular motility or visual function (e.g., multiple sclerosis; cranial nerve III, IV, V, or VI palsy). * Manifest ocular deviation not suitable for management with visual therapy. * Inadequate refractive correction or prism requirement \>10 prism diopters (\>10Δ). * Refractive surgery (LASIK/PRK), cataract surgery, or any ocular surgery likely to influence binocular vision within the past 6 months. * Use of medications known to affect ocular motility or accommodative function. * Cognitive impairment or neurological conditions interfering with adherence to therapy instructions. * Suppression or severe amblyopia limiting response to visual therapy. * Best-corrected visual acuity \<0.5 decimal (equivalent to worse than 20/40) at distance or near.

Conditions

Vergence Disorders Binocular Vision Dysfunction Convergence Insufficiency

Locations

  • Jordi Zaragoza osteopatia — Andorra la Vella, Andorra, Andorra
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record