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NCT Number: NCT07036263

Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency

The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency.

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Key information

Conditions

Convergence Insufficiency Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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;
  • Diagnosis of diabetic polyneuropathy;
  • Use of joint prostheses;
  • Ongoing physical therapy treatment;
  • Lack of physical ability to perform the prescribed physical activities.

Treatment and study plan

Oculomotor therapy

Other

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 Added

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Single-Leg Stance Test

    Time frame: 3 months

    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.

  2. Postural Control Assessment

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

"Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency: A Blind Randomized Clinical Trial"

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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