Evaluating balance in patients with strabismus undergoing surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with strabismus, a condition where the eyes do not align properly. Participants will be recruited from the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and will be divided into two groups based on whether their strabismus is congenital or acquired. Each patient will undergo a thorough ophthalmologic and balance assessment before surgery and at multiple follow-up points post-surgery to evaluate changes in balance and fall risk. The goal is to understand how strabismus surgery impacts balance and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Annabella Salerni, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Annabella Salerni, MD
• Email: annabella.salerni@policlinicogemelli.it
• Phone: +390630154382

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.