Balance in the Strabismic Patient Undergoing Strabismus Surgery

NCT06733220 | Recruiting

• 1 other identifier: 7161
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Strabismus

Keywords

Strabismus; Balance; Risk of falling; Quality of life

Outcome Measures

Primary Outcomes (1)

• Dynamic balance

  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

  Change from Baseline Dynamic Balance at 30, 90 and 180 days

Secondary Outcomes (13)

• Cover/Uncover test

  Change from Baseline Cover/Uncover test at 30, 90 and 180 days

• Cover test with prisms

  Change from Baseline Cover test with prisms at 30, 90 and 180 days

• Irvine test

  Change from Baseline Irvine test at 30, 90 and 180 days

• Angle measurement in the various positions of gaze

  Change from Baseline angle measurement at 30, 90 and 180 days

• Bagolini's Streaked Glasses

  Change from Baseline Bagolini's Streaked Glasses at 30, 90 and 180 days

Study Arms (2)

STR-CONG

Patients with congenital strabismus will undergo a comprehensive eye and orthoptic examination and balance test before strabismus surgery at 30 days after surgery, at 90 days after surgery, and at 180 days after surgery.

Procedure: Surgery for strabismus

STR-ACQ

Patients with acquired strabismus will undergo a comprehensive eye and orthoptic examination and balance test before strabismus surgery, at 30 days after surgery, at 90 days after surgery, and at 180 days after surgery.

Procedure: Surgery for strabismus

Interventions

Surgery for strabismus PROCEDURE

Patients will undergo surgery to correct strabismus, congenital or acquired

STR-ACQ; STR-CONG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with strebismus, congenital or acquired, who will have surgery for surgical correction of strabismus during the study period will be included.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Strabismus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Annabella Salerni, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabella Salerni, MD

CONTACT

+390630154382; annabella.salerni@policlinicogemelli.it

Letizia Castelli, PhD

CONTACT

+390630154382; letizia.castelli@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: February 5, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)