Comparing two surgical methods for treating eye muscle issues in children
Inferior Oblique Muscle Belly Transposition (IOBT) Versus Inferior Oblique Muscle Recession (IO-rec) on Versions and Vertical Alignment for Primary Position Hypertropia With Inferior Oblique Overaction
This study is testing two different eye surgeries to see which one works better for children with eye muscle problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05415553 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, randomized double-blind controlled trial aimed at comparing the effectiveness of inferior oblique muscle belly transposition (IOBT) versus inferior oblique recession (IO-Rec) in treating hypertropia associated with inferior oblique overaction (IOOA). The study will evaluate the rates of surgical success and suboptimal outcomes between the two surgical techniques. Conducted across nine pediatric ophthalmology centers, each site will have a certified surgeon performing the procedures. The trial aims to provide robust evidence regarding the efficacy of IOBT as a potential alternative to IO-Rec.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 years and older with specific vertical deviations and inferior oblique overaction.
Not a fit: Patients with a history of strabismus surgery, amblyopia, or other significant ocular or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes for children with hypertropia and inferior oblique overaction.
How similar studies have performed: Previous studies have shown promising results for IOBT, but this trial is necessary to establish its efficacy compared to IO-Rec in a larger population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 4 years at the time of surgery; * Vertical deviation (VD) in primary position (5△ ≤ VD ≤ 10△) * IOOA for three following situations: 1. IOOA +1 for the operative eye and IOOA - for the follow eye; 2. IOOA +2 for the operative eye and IOOA ± for the follow eye; 3. IOOA +2 for the operative eye and IOOA +1 for the follow eye; * Without amblyopia Exclusion Criteria: * Histories of strabismus surgery or botulinum toxin injection; * Histories of intraocular surgery or refractive surgery; * Restrictive or paralytic strabismus; * Ocular disease other than strabismus or refractive error; * Craniofacial malformations affecting the orbits; * Significant neurological disorders
Where this trial is running
Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chen Zhao
- Email: dr_zhaochen@163.com
- Phone: +86-021-6437-7134
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.