Evaluating balance in patients with strabismus undergoing surgery
Assessment of Balance in the Strabismic Patient Undergoing Strabismus Surgery
This study is testing how surgery for strabismus affects balance and the risk of falling in patients with this eye condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06733220 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 65 with either congenital or acquired strabismus who can maintain balance for at least 180 seconds.
Not a fit: Patients with diplopia associated with nystagmus or significant cognitive delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of balance issues in strabismic patients, potentially leading to better surgical outcomes and enhanced quality of life.
How similar studies have performed: While studies on strabismus have been conducted, this specific focus on balance post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.