Effectiveness of Osteopathy as an Adjunct to Optometric Vision Therapy in Vergence Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJordi Zaragoza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Optometric Vision Therapy
BehavioralStructured 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
BehavioralStandardized 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
BehavioralSham 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Vision Therapy AloneActive comparator 1 intervention
Group B: Vision Therapy + Osteopathic TreatmentExperimental treatment 2 interventions
Group C: Vision Therapy + Sham Osteopathic InterventionSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in vergence reaction latency measured by video-oculography (REMOBI and EyeSeeCam)
Reaction latency (milliseconds) during standardized binocular convergence and divergence tasks recorded using video-oculography systems (REMOBI and EyeSeeCam). Lower latency values indicate better vergence motor performance.
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.2
Change in vergence amplitude variability measured by video-oculography (REMOBI and EyeSeeCam)
Variability of vergence response amplitude (%) during standardized binocular convergence and divergence tasks recorded using video-oculography systems (REMOBI and EyeSeeCam). Higher variability indicates lower stability of vergence motor control.
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.3
Change in vergence amplitude error measured by video-oculography (REMOBI and EyeSeeCam)
Amplitude error (%) of vergence responses relative to the target stimulus during standardized convergence and divergence tasks, automatically quantified by video-oculography systems (REMOBI and EyeSeeCam). Lower error values indicate more accurate vergence performance.
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.4
Change in vergence neglect rate measured by video-oculography (REMOBI and EyeSeeCam)
Neglect rate (%) defined as the proportion of trials with absent or undetected vergence response during standardized convergence and divergence tasks, recorded automatically by video-oculography systems (REMOBI and EyeSeeCam). Lower neglect rates indicate improved vergence function.
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.Secondary outcomes
1
Change in Convergence Insufficiency Symptom Survey score (CISS-V15)
Total score of the Convergence Insufficiency Symptom Survey (CISS-V15; range 0-60). Higher scores indicate greater symptom burden related to binocular vision dysfunction.
Time frame
Baseline (pre-intervention); immediately after the post-intervention assessment (within 2 weeks after the last visual therapy session); 3 months after post-intervention assessment; 6 months after post-intervention assessment.Sponsors and contacts
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Jordi Zaragoza
Lead sponsor
Jordi Zaragoza Bort
Sponsor institution
Source ClinicalTrials.gov
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