Actively Recruiting

Age: 16Years - 65Years
All Genders
ID06733220

Assessment of Balance in Patients with Congenital or Acquired Strabismus Undergoing Surgery

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-04

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Strabismus is a condition where the eyes do not align properly on a focused object, caused by issues such as congenital or acquired factors and affecting eye movement. It can lead to symptoms like diplopia or confusion in adults, while children may compensate for misalignment without diplopia. This research investigates how strabismus surgery impacts balance and postural control, building on limited prior studies that suggest surgery may improve balance by affecting eye muscle sensory functions. Patients with either congenital or acquired strabismus will be enrolled and divided into two groups accordingly. All participants will undergo comprehensive eye and orthoptic examinations along with balance assessments before surgery and at 30, 90, and 180 days after the surgical procedure to correct their eye alignment. Throughout the study, participants will be evaluated at multiple time points with tests measuring eye function and balance, including dynamic balance and various vision tests. The primary outcome is the change in dynamic balance from baseline at each follow-up. Secondary measures include detailed eye movement and binocular vision tests. Safety and ability to maintain balance for extended periods are also monitored during the six-month follow-up period.

CONDITIONS

Brief Title

Balance in the Strabismic Patient Undergoing Strabismus Surgery

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 65 years
  • Presence of congenital or acquired strabismus under care at specified ophthalmology clinics
  • Ability to safely maintain balance for at least 180 seconds
  • Ability to understand and sign informed consent if an adult
  • Ability to understand and assent and parental consent if a minor
Not Eligible

You will not qualify if you...

  • Presence of diplopia associated with nystagmus
  • Psychomotor and cognitive delay as assessed by Mini Mental State Examination (score below 24)
  • Patient noncooperation
  • Inability to provide informed consent for adults
  • Inability to provide assent or parental consent for minors

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo surgery to correct strabismus, either congenital or acquired.

1 visit (in-person)

Post-operative Follow-up

Duration - 180 days

Participants have clinical evaluations and assessments of balance and fall risk after surgery at 30, 90, and 180 days.

3 visits (in-person) at 30, 90, and 180 days after surgery

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy, 00168

Actively Recruiting

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Research Team

A

Annabella Salerni, MD

L

Letizia Castelli, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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