An interventional study of IOBT and IO-Rec in Hypertropia and Inferior Oblique Overaction, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2022-07-29.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's planned enrollment of 190 is above the median of 60 across 82 interventional studies indexed under Strabismus.
Browse Strabismus studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
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IOOA for three following situations:
Exclusion Criteria:
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
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
Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction
Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction
Suboptimal surgical rate
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
Time frame: at 12 months
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.
Time frame: at 12 month
Plan to share: No — We concerns about patient privacy issues and it's better to protect the publication potential.
Started Jul 2022 (actual). Primary completion is estimated for Jun 2025, 35 months after the start.
Of 35 non-industry interventional studies with no phase under Strabismus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 35 months is above that.
Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 46.
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