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Recruiting Observational

Balance in the Strabismic Patient Undergoing Strabismus Surgery

NCT06733220 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-05
Last updated
2025-03-04

Condition(s) studied

Strabismus

Investigational drug(s) / intervention(s)

Surgery for strabismus

Surgery for strabismus: Patients will undergo surgery to correct strabismus, congenital or acquired

Study summary

Strabismus is a clinical condition characterized by the failure of the visual axes of the two eyes to align on the stared object. There are many possible causes of strabismus, but it can be divided into two main groups: concomitant strabismus, which is characterized by an almost equal angle of deviation in all positions of gaze, and incomitant or paralytic strabismus, which is characterized by a deficit of ocular motility in one or more directions of gaze. Depending on the age of onset, congenital strabismus and acquired strabismus are distinguished. Concomitant strabismus and incomitant strabismus can occur in both plastic age and adults. They are accompanied by diplopia or confusion if they arise in adulthood; there is no diplopia if they arise in plastic age due to cortical compensation mechanisms such as suppression or abnormal retinal matching. Causes of incomitant strabismus in adults can be: decompensation of a preexisting heterophoria; acute incomitant strabismus; injury to fusional centers. Paralytic incomitant strabismus is characterized by a reduction in the force developed by one or more muscles of an eye. Among incomitant strabismus, restrictive strabismus represent clinical pictures of very different etiology united by a single distinguishing feature: the existence of a mechanical obstacle to the free movement of the bulb in the orbit that prevents or reduces the excursion of the eye in one or more directions of gaze.

In about 4% of the young population, the sensory and/or motor pathways are not adequately developed, resulting in misalignment of the visual axes and strabismus. Eye surgery for strabismus is one of the most widely used treatment methods.

Only a few studies in the literature have analyzed changes in postural control after strabismus surgery and on a limited number of patients.

A French study evaluated the effect of surgery on postural control in children with strabismus, concluding that eye surgery affects the somatosensory properties of extraocular muscles, leading to improved postural control and that binocular visual perception could affect the whole body.

Eligibility

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 16 and 65 years; * Presence of congenital strabismus or acquired strabismus in the care of the Ophthalmology OU, the Diagnosis and Treatment of Ocular Motility Disorders OU, and the Pediatric Ophthalmology Outpatient Clinic * Ability to maintain balance safely for at least 180 seconds; * In case of adult patient, Ability to understand and sign informed consent * In case of minor patient, Ability to understand and sign the assent for participation in the study and consent from the parent Exclusion Criteria: * Presence of diplopia associated with nystagmus; * Presence of psychomotor and cognitive delay, as assessed by the Mini Mental State Examination (adjusted score \< 24); * Noncooperation of the patient; * Inability to provide informed consent, in the case of adult patients. * Inability to provide consent in case of minor patients, or consent from parents.

Primary outcome measure(s)

  • Dynamic balance — Change from Baseline Dynamic Balance at 30, 90 and 180 days
    Dynamic balance will be assessed using a robotic platform. Specifically, the reduction in the displacement of the center of pressure under dynamic conditions will be evaluated

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06733220 on ClinicalTrials.gov ↗ ← All trials in Italy