NCT07036263

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 12, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

Convergence insufficiencyPostural controlClinical trial

Outcome Measures

Primary Outcomes (1)

  • General mobility

    General mobility will be assessed using the Timed 'Up-and-Go' test with time measured in seconds as the unit of measurement.

    3 months

Secondary Outcomes (2)

  • Single-Leg Stance Test

    3 months

  • Postural Control Assessment

    3 months

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

This group will receive treatment with oculomotor therapy

Other: Oculomotor therapy

Control group (CG)

OTHER

This group will not receive any type of treatment

Other: No Treatment Added

Interventions

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.

Experimental Group (EG)

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

Control group (CG)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment randomised clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 25, 2025

Study Start

August 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share