AzTrials
AzTrials

Vergence DisordersOSTEOVERGNCT07452679

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

A study testing Optometric Vision Therapy and Osteopathic Manual Therapy in people with Vergence Disorders and Binocular Vision Dysfunction, run by Jordi Zaragoza at 1 site in Andorra.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Optometric Vision Therapy and Osteopathic Manual Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteAndorra
Study dates
7 Sep 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JORDI Z ZARAGOZA BORT, MSc contact

+376342813

jzaragozaosteopatia@gmail.com

JORDI Z ZARAGOZA BORT, DO contact

+376828783

jordi_zaragoza_bort@hotmail.com

Andorra1 site, 1 recruiting
  • Jordi Zaragoza osteopatia

    Andorra la Vella, Andorra, AD500

    JORDI Z ZARAGOZA BORT, MSc, +376828783, jzaragozaosteopatia@gmail.com

    Recruiting

About this study

Official title: Effectiveness of Osteopathy as an Adjunct to Optometric Vision Therapy in Subjects With Vergence Disorders: A Randomized, Double-Blind, Controlled Clinical 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.

Read the detailed description

Vergence disorders are binocular vision dysfunctions characterized by an impaired ability to coordinate eye movements during visual tasks, particularly at near distances. These disorders are associated with a range of symptoms, including visual discomfort, reduced visual efficiency, and decreased functional performance during sustained near-vision activities.

Optometric vision therapy is an evidence-based intervention aimed at improving vergence function and visual efficiency. Despite its effectiveness, clinical response varies among individuals, and a subset of participants may continue to experience persistent symptoms. This variability has prompted interest in adjunctive interventions that may influence neuromuscular, musculoskeletal, or functional components related to oculomotor control.

This study is designed as a randomized, controlled, double-blind clinical trial with three parallel arms. Participants diagnosed with vergence disorders will be randomly assigned to one of the following groups: (1) optometric vision therapy combined with osteopathic treatment, (2) optometric vision therapy combined with a sham osteopathic intervention, or (3) optometric vision therapy alone.

The primary objective of the study is to evaluate whether the addition of osteopathy to optometric vision therapy results in greater improvements in ocular mobility and efficiency, assessed using video-oculography systems (REMOBI and EyeSeeCam). Secondary objectives include the evaluation of symptom changes associated with vergence disorders using a validated questionnaire (CISS-V15), as well as the exploration of potential relationships between functional ocular impairment, identified somatic dysfunctions, and the anatomical distribution of reported symptoms.

Ocular motor performance will be objectively quantified through standardized vergence tasks recorded by video-oculography, including measures of reaction latency, amplitude variability, amplitude error, and neglect rate. Assessments will be conducted at baseline (pre-intervention), post-intervention (within two weeks after completion of the visual therapy program), and at follow-up time points of three and six months after the intervention.

The osteopathic intervention consists of a standardized manual treatment protocol targeting somatic dysfunctions potentially related to binocular vision and vergence function. The sham osteopathic intervention is designed to mimic the context, duration, and therapist-participant interaction of the active manual treatment without applying therapeutic osteopathic techniques, in order to preserve participant blinding.

The results of this study are expected to contribute to a better understanding of the potential role of osteopathy as an adjunctive intervention in the management of vergence disorders and to provide clinically relevant data on the relationship between somatic dysfunctions and functional visual alterations in individuals with high visual demand.

Being tested
Optometric Vision Therapy, Osteopathic Manual Therapy, Sham Osteopathic Intervention
Keywords
Optometric Vision Therapy, Osteopathy, Sham Intervention, Video-oculography, Ocular Motility, Visual Symptoms, Randomized Controlled Trial
Medical subject headings
Ocular Motility Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optometric Vision TherapyBehavioural

    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 TherapyBehavioural

    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 InterventionBehavioural

    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 groups in NCT07452679
Study groupRoleWhat they receive
Vision Therapy AloneActive comparatorParticipants receive optometric vision therapy alone, consisting of structured in-office and home-based exercises targeting vergence and binocular vision dysfunctions.
Receives: Behavioral: Optometric Vision Therapy
Vision Therapy + Osteopathic TreatmentExperimentalParticipants 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.
Receives: Behavioral: Optometric Vision Therapy; Behavioral: Osteopathic Manual Therapy
Vision Therapy + Sham Osteopathic InterventionSham comparatorParticipants 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).
Receives: Behavioral: Optometric Vision Therapy; Behavioral: Sham Osteopathic Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)
  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start7 Sep 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452679
Sponsor's protocol ID
JZB-OPT-OST-01
Other IDs
JZB-OPT-OST-01
Acronym
OSTEOVERG
Status last verified
Oct 2026
First submitted
11 Feb 2026
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rankin EA, Delashmutt MB. Finding spirituality and nursing presence: the student's challenge. J Holist Nurs. 2006 Dec;24(4):282-8. doi: 10.1177/0898010106294423.

    PubMed 17098882
  • DeMatteo RP, Maki RG, Singer S, Gonen M, Brennan MF, Antonescu CR. Results of tyrosine kinase inhibitor therapy followed by surgical resection for metastatic gastrointestinal stromal tumor. Ann Surg. 2007 Mar;245(3):347-52. doi: 10.1097/01.sla.0000236630.93587.59.

    PubMed 17435539
  • Walker D. Autophagy: a new link in the chain. Nat Rev Mol Cell Biol. 2010 Sep;11(9):604-5. doi: 10.1038/nrm2954. Epub 2010 Aug 4. No abstract available.

    PubMed 20683468
  • Brugger B. Lipidomics: analysis of the lipid composition of cells and subcellular organelles by electrospray ionization mass spectrometry. Annu Rev Biochem. 2014;83:79-98. doi: 10.1146/annurev-biochem-060713-035324. Epub 2014 Mar 3.

    PubMed 24606142
  • Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336.

    PubMed 18852411
  • Challacombe SJ, Scully C, Keevil B, Lehner T. Serum ferritin in recurrent oral ulceration. J Oral Pathol. 1983 Aug;12(4):290-9. doi: 10.1111/j.1600-0714.1983.tb00339.x.

    PubMed 6411882
  • Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90. doi: 10.1111/j.1475-1313.2004.00202.x.

    PubMed 15315652
  • Pringuey D, Fakra E, Cherikh F, Jover F, Giordana B, Clad C, Kohl F, Azorin JM. [Endophenotypes of the biorhythms and the sleep in depression]. Encephale. 2012 Dec;38 Suppl 3:S116-20. doi: 10.1016/S0013-7006(12)70089-1. French.

    PubMed 23279985
  • SPIRIT 2013 24606142

Questions about this trial

What is this clinical trial studying?

A study testing Optometric Vision Therapy and Osteopathic Manual Therapy in people with Vergence Disorders and Binocular Vision Dysfunction, run by Jordi Zaragoza at 1 site in Andorra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Andorra. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JORDI Z ZARAGOZA BORT, MSc (+376342813, jzaragozaosteopatia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07452679, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in