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

Sponsor
Jordi Zaragoza
Study ID
NCT07452679
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Vision Therapy Alone
    Participants receive optometric vision therapy alone, consisting of structured in-office and home-based exercises targeting vergence and binocular vision dysfunctions.
  • Experimental: Vision Therapy + Osteopathic Treatment
    Participants receive two sessions of standardized osteopathic manual treatment separated by approximately three weeks, followed by a structured optometric vision therapy program consisting of 8 sessions delivered at a frequency of 1-2 sessions per week.
  • Sham Comparator: Vision Therapy + Sham Osteopathic Intervention
    Participants receive two sessions of a standardized sham osteopathic intervention separated by approximately three weeks, designed to mimic the context and duration of manual treatment without applying therapeutic techniques, followed by the same structured optometric vision therapy program (8 sessions, 1-2 sessions per week).

Primary Outcome Measure

Change in vergence reaction latency measured by video-oculography (REMOBI and EyeSeeCam) [ Time Frame: Baseline (pre-intervention); post-intervention (within 2 weeks after the last visual therapy session); 3 months after post-intervention assessment; 6 months after post-intervention assessment. ]

Central Contacts

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