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

NCT07452679 | Not Yet Recruiting

• 1 other identifier: JZB-OPT-OST-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vergence Disorders; Binocular Vision Dysfunction; Convergence Insufficiency

Keywords

Optometric Vision Therapy; Osteopathy; Sham Intervention; Video-oculography; Ocular Motility; Visual Symptoms; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

• 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.

  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.

• 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.

  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.

• 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.

  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)

  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.

Study Arms (3)

Vision Therapy Alone

ACTIVE COMPARATOR

Participants receive optometric vision therapy alone, consisting of structured in-office and home-based exercises targeting vergence and binocular vision dysfunctions.

Behavioral: Optometric Vision Therapy

Vision Therapy + Osteopathic Treatment

EXPERIMENTAL

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.

Behavioral: Optometric Vision Therapy; Behavioral: Osteopathic Manual Therapy

Vision Therapy + Sham Osteopathic Intervention

SHAM COMPARATOR

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).

Behavioral: Optometric Vision Therapy; Behavioral: Sham Osteopathic Intervention

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.

Vision Therapy + Osteopathic Treatment; Vision Therapy + Sham Osteopathic Intervention; Vision Therapy Alone

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.

Vision Therapy + Osteopathic Treatment

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.

Vision Therapy + Sham Osteopathic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordi Zaragoza: lead

Study Sites (1)

Jordi Zaragoza osteopatia

Andorra la Vella, Andorra, AD500, Andorra

Location

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• SPIRIT 2013 24606142

  BACKGROUND

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• JORDI Z ZARAGOZA BORT, DO

  Private Practice, Andorra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JORDI Z ZARAGOZA BORT, MSc

CONTACT

+376342813; jzaragozaosteopatia@gmail.com

JORDI Z ZARAGOZA BORT, DO

CONTACT

+376828783; jordi_zaragoza_bort@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Participants and Outcomes Assessors). The osteopathic treatment provider is not blinded due to the nature of the manual intervention. Participants are unaware of group allocation, and the sham intervention is designed to mimic the context, duration, and therapist-participant interaction of the active osteopathic treatment to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, double-blind clinical trial with three parallel arms comparing: (1) optometric vision therapy combined with osteopathic treatment; (2) optometric vision therapy combined with sham osteopathic intervention; and (3) optometric vision therapy alone. Participants and outcome assessors will be blinded to group allocation.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)