IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)

Study Overview
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Brief Summary
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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 suboptimal surgical rates between IOBT and IO-Rec for the treatment of hypertropia with IOOA. Specific Aim 2 (Secondary): To compare the surgical successful rate of IOBT with IO-Rec for the treatment of hypertropia with IOOA.

Detailed Description
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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 primary position hypertropia with unilateral IOOA. To achieve better outcome, IOBT was introduced. Yang et al. firstly reported that IOBT might be a useful alternative surgical treatment for patients with primary position hypertropia of less than 5△ that was associated with IOOA. Recently, our study has reported that IOBT achieved satisfactory outcomes in patients with mild primary position vertical deviation (≤10△) with unilateral IOOA, without any risk of overcorrection of vertical deviation and contralateral IOOA. Although our results are promising, there is no enough evidence to recommend IOBT for primary position hypertropia with inferior oblique overaction. A large randomized trial is needed to compare the surgical successful rate and suboptimal surgical outcomes of IOBT with IO-Rec for primary position hypertropia with inferior oblique overaction. The proposed trial will be conducted in 9 different study sites working in the field of pediatric ophthalmology and strabismus. Each site will have one certified surgeon to do all surgeries. For IOBT, the whole belly of inferior oblique muscle is secured with a 6-0 absorbable suture, and then anchors to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle. For IO-Rec, the insertion of inferior oblique muscle is excised and secured with a 6-0 absorbable suture, and then anchors to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle.

Official Title
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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

Conditions
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Hypertropia, Inferior Oblique Overaction

Intervention / Treatment
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* Procedure: IOBT
* Procedure: IO-Rec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOBT group<br>For IOBT, the whole belly of inferior oblique muscle is anchored to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle. | Procedure: IOBT<br>* Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction<br>|
| Active Comparator: IO-Rec group<br>For IO-Rec, the insertion of inferior oblique muscle is excised and anchored to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle. | Procedure: IO-Rec<br>* Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suboptimal surgical rate | Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome. | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical successful rate | Surgical successful cases/total cases. The successful criterion is without any vertical deviation in primary position at distance and without IOOA postoperatively. | at 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inferior oblique muscle belly transposition, Inferior oblique muscle recession, Inferior oblique overaction