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Search / Trial NCT06733220

Balance in the Strabismic Patient Undergoing Strabismus Surgery

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Dec 10, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Strabismus Balance Risk Of Falling Quality Of Life

ClinConnect Summary

This clinical trial is studying how strabismus surgery affects balance in patients with misaligned eyes, a condition known as strabismus. Strabismus can make it difficult for the eyes to work together, which can lead to problems with vision and balance. The researchers want to see if correcting the eye alignment through surgery can improve a person's ability to maintain their balance. This study is particularly focused on understanding the changes in how the body controls posture after surgery.

To be eligible for this trial, participants should be between 16 and 65 years old and have either congenital (present at birth) or acquired strabismus. They must also be able to stand still for at least three minutes and be able to understand and agree to participate in the study. Participants will undergo assessments related to their balance before and after the surgery. It’s important to note that individuals with specific eye problems, cognitive delays, or who cannot cooperate will not be eligible to join. This trial aims to help improve our understanding of how eye surgery might not only fix vision but also enhance overall body control.

Gender

ALL

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, Rm, Italy

Patients applied

0 patients applied

Trial Officials

Annabella Salerni, MD

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported