Convergence InsufficiencyNCT07036263
Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency
A study testing Oculomotor therapy and No Treatment Added in people with Convergence Insufficiency, run by University of Nove de Julho.
Trial summary
The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Oculomotor therapy and No Treatment Added
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Dec 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with convergence insufficiency (CI);
- Aged between 18 and 60 years;
- Physically active individuals;
- Without cognitive impairments;
- Without vestibular system impairments (e.g., dizziness).
Who cannot join
- Diagnosis of neurodegenerative diseases (e.g., Parkinson's, ALS);
- Presence of dementia;
- History of stroke;
- Presence of vestibular disorders;
- Systemic neuromuscular diseases;
- Disabling musculoskeletal pain;
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- Diagnosis of diabetic polyneuropathy;
- Use of joint prostheses;
- Ongoing physical therapy treatment;
- Lack of physical ability to perform the prescribed physical activities.
About this study
Official title: "Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency: A Blind Randomized Clinical Trial"
The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency.
Read the detailed description
Seventy participants with convergence insufficiency (CI) will be randomly allocated into two groups: Experimental Group (EG) (n=35) and Control Group (CG) (n=35). The primary outcome will be CI assessed by the convergence test. Secondary outcomes will include quality of life, postural balance, and gait speed. The EG will undergo five sessions of oculomotor therapy (once a week), based on and adapted from the established protocol for CI treatment. Results: Outcomes will be assessed by blinded evaluators at baseline, one week after the end of the treatment, and at 1 and 3 months follow-up. The CG will not receive any intervention. Data will be analyzed using statistical tests with a significance level set at p < 0.05.
- Conditions
- Convergence Insufficiency
- Being tested
- Oculomotor therapy, No Treatment Added
- Keywords
- Convergence insufficiency, Postural control, Clinical 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.
Oculomotor therapyOther
Oculomotor therapy will follow and adapt the protocol for treating convergence insufficiency (CI). Procedures will be organized progressively, from easiest to most difficult. Gross convergence techniques: (1) Brock String: A 1.5-2 m cord with colored beads; the patient focuses on each bead to train binocular fusion, observing the "X" shape of the cord. (2) Barillé Chart: A card with paired images for each eye; the patient merges the images into one using convergence and sensory fusion. Accommodative techniques: (1) Eccentric Circles: Printed circles with eccentric marks; viewed through filters to train motor and sensory fusion by aligning them into a single 3D image. (2) Opaque Lifesaver Cards: Cards with figures on an opaque background, used with red-green filters to stimulate convergence and fixation by reducing peripheral stimuli and enhancing visual attention.
No Treatment AddedOther
Participants in the control group will not receive any type of treatment for a period of five weeks. After this period, they will be re-evaluated
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | This group will receive treatment with oculomotor therapy Receives: Other: Oculomotor therapy |
| Control group (CG) | Other | This group will not receive any type of treatment Receives: Other: No Treatment Added |
What is being measured
The primary outcome is the main question the study is designed to answer.
General mobility
General mobility will be assessed using the Timed 'Up-and-Go' test with time measured in seconds as the unit of measurement.
Measured: 3 months
Secondary outcomes (2)
Single-Leg Stance Test
The single-leg stance test is used to assess static balance and predict frailty, particularly in community-dwelling older adults. Participants will be asked to stand on one leg for a maximum of 30 seconds, first with eyes open and then with eyes closed. The duration will be measured in three trials per visual condition, and the longest time will be considered. Longer stance duration indicates better balance. The examiner will remain beside the participant to prevent any risk of falling.
Measured: 3 months
Postural Control Assessment
Postural control will be evaluated using a force platform (BIOMEC 400 v1.1, EMG System Ltda®). Tests will be performed under four conditions: (1) eyes open; (2) eyes closed; (3) eyes open, single-leg stance (dominant leg); and (4) eyes closed, single-leg stance (dominant leg). The main parameters will be the center of pressure (CoP) sway velocity (cm/s), in both anteroposterior (AP) and mediolateral (ML) directions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Assignment randomised clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiano Politti, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036263
- Sponsor's protocol ID
- CI-2025
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency: A Blind Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07036263
- Acronym / sponsor ID
- CI-2025
- Conditions
- Convergence Insufficiency
- Keywords
- Convergence insufficiency, Postural control, Clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency.
Detailed description
Seventy participants with convergence insufficiency (CI) will be randomly allocated into two groups: Experimental Group (EG) (n=35) and Control Group (CG) (n=35). The primary outcome will be CI assessed by the convergence test. Secondary outcomes will include quality of life, postural balance, and gait speed. The EG will undergo five sessions of oculomotor therapy (once a week), based on and adapted from the established protocol for CI treatment. Results: Outcomes will be assessed by blinded evaluators at baseline, one week after the end of the treatment, and at 1 and 3 months follow-up. The CG will not receive any intervention. Data will be analyzed using statistical tests with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Other: Oculomotor therapyThis group will receive treatment with oculomotor therapy |
| Control group (CG) | Other | Other: No Treatment AddedThis group will not receive any type of treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with convergence insufficiency (CI);
- Aged between 18 and 60 years;
- Physically active individuals;
- Without cognitive impairments;
- Without vestibular system impairments (e.g., dizziness).
Key exclusion criteria (10 listed)
- Diagnosis of neurodegenerative diseases (e.g., Parkinson's, ALS);
- Presence of dementia;
- History of stroke;
- Presence of vestibular disorders;
- Systemic neuromuscular diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculomotor therapyOculomotor therapy will follow and adapt the protocol for treating convergence insufficiency (CI). Procedures will be organized progressively, from easiest to most difficult. Gross convergence techniques: (1) Brock String: A 1.5-2 m cord with colored beads; the patient focuses on each bead to train binocular fusion, observing the "X" shape of the cord. (2) Barillé Chart: A card with paired images for each eye; the patient merges the images into one using convergence and sensory fusion. Accommodative techniques: (1) Eccentric Circles: Printed circles with eccentric marks; viewed through filters to train motor and sensory fusion by aligning them into a single 3D image. (2) Opaque Lifesaver Cards: Cards with figures on an opaque background, used with red-green filters to stimulate convergence and fixation by reducing peripheral stimuli and enhancing visual attention. | Other | Experimental Group (EG) |
| No Treatment AddedParticipants in the control group will not receive any type of treatment for a period of five weeks. After this period, they will be re-evaluated | Other | Control group (CG) |
Primary outcome
General mobility
Time frame: 3 months
General mobility will be assessed using the Timed 'Up-and-Go' test with time measured in seconds as the unit of measurement.
2 secondary outcomes
Single-Leg Stance Test
Time frame: 3 months
Postural Control Assessment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oculomotor therapy and No Treatment Added in people with Convergence Insufficiency, run by University of Nove de Julho.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General mobility (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.