Status:
UNKNOWN
IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Collaborating Sponsors:
Children's Hospital of Fudan University
Shandong Provincial Hospital
Conditions:
Hypertropia
Inferior Oblique Overaction
Eligibility:
All Genders
4+ years
Phase:
NA
Brief Summary
This is a multi-center, randomized double-blind controlled trial to compare the effectiveness of IOBT with IO-Rec for the treatment of hypertropia with IOOA. Specific Aim 1 (Primary): To study the su...
Detailed Description
Using conventional surgical procedures, such as myectomy or recession of inferior oblique muscle, higher postoperative vertical overcorrection due to contralateral concealed IOOA were observed in mild...
Eligibility Criteria
Inclusion
- Age ≥ 4 years at the time of surgery;
- Vertical deviation (VD) in primary position (5△ ≤ VD ≤ 10△)
- IOOA for three following situations:
- IOOA +1 for the operative eye and IOOA - for the follow eye;
- IOOA +2 for the operative eye and IOOA ± for the follow eye;
- IOOA +2 for the operative eye and IOOA +1 for the follow eye;
- Without amblyopia
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05415553
Start Date
July 1 2022
End Date
June 30 2025
Last Update
July 29 2022
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, China