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

Hypertropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415553
• Other study ID #: 2022-IOBT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Chen Zhao
• Phone: +86-021-6437-7134
• Email: dr_zhaochen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertropia
• Strabismus

Intervention

Procedure:
• IOBT
Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction
• IO-Rec
Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Children's Hospital of Fudan University, Kunming Aier Eye Hospital, Renmin Hospital of Wuhan University, Shandong Provincial Hospital, Shanxi Eye Hospital, Tianjin Eye Hospital, Xiamen Eye Center of Xiamen University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (11)

Akbari MR, Sadrkhanlou S, Mirmohammadsadeghi A. Surgical Outcome of Single Inferior Oblique Myectomy in Small and Large Hypertropia of Unilateral Superior Oblique Palsy. J Pediatr Ophthalmol Strabismus. 2019 Jan 23;56(1):23-27. doi: 10.3928/01913913-20180925-03. Epub 2018 Oct 26. — View Citation

Alajbegovic-Halimic J, Zvizdic D, Sahbegovic-Holcner A, Kulanic-Kuduzovic A. Recession Vs Myotomy-Comparative Analysis of Two Surgical Procedures of Weakening Inferior Oblique Muscle Overaction. Med Arch. 2015 Jun;69(3):165-8. doi: 10.5455/medarh.2015.69.165-168. Epub 2015 Jun 10. — View Citation

Bahl RS, Marcotty A, Rychwalski PJ, Traboulsi EI. Comparison of inferior oblique myectomy to recession for the treatment of superior oblique palsy. Br J Ophthalmol. 2013 Feb;97(2):184-8. doi: 10.1136/bjophthalmol-2012-301485. Epub 2012 Nov 30. — View Citation

Bhatta S, Auger G, Ung T, Burke J. Underacting inferior oblique muscle following myectomy or recession for unilateral inferior oblique overaction. J Pediatr Ophthalmol Strabismus. 2012 Jan-Feb;49(1):43-8. doi: 10.3928/01913913-20110208-02. Epub 2011 Feb 15. — View Citation

Hendler K, Pineles SL, Demer JL, Rosenbaum AL, Velez G, Velez FG. Does inferior oblique recession cause overcorrections in laterally incomitant small hypertropias due to superior oblique palsy? Br J Ophthalmol. 2013 Jan;97(1):88-91. doi: 10.1136/bjophthalmol-2012-302006. Epub 2012 Nov 10. — View Citation

Kasem M, Metwally H, El-Adawy IT, Abdelhameed AG. Retro-equatorial inferior oblique myopexy for treatment of inferior oblique overaction. Graefes Arch Clin Exp Ophthalmol. 2020 Sep;258(9):1991-1997. doi: 10.1007/s00417-020-04742-4. Epub 2020 May 27. — View Citation

Nabie R, Raoufi S, Hassanpour E, Nikniaz L, Kharrazi B, Mamaghani S. Comparing graded anterior transposition with myectomy in primary inferior oblique overaction - A clinical trial. J Curr Ophthalmol. 2019 May 8;31(4):422-425. doi: 10.1016/j.joco.2019.04.002. eCollection 2019 Dec. — View Citation

Shipman T, Burke J. Unilateral inferior oblique muscle myectomy and recession in the treatment of inferior oblique muscle overaction: a longitudinal study. Eye (Lond). 2003 Nov;17(9):1013-8. — View Citation

Tomarchio S, Sabetti L, Tomarchio M, Berarducci A. New surgical intervention for the weakening of the inferior oblique muscle: equatorial scleral anchor. J Pediatr Ophthalmol Strabismus. 2015 Jan-Feb;52(1):58-60. doi: 10.3928/01913913-20141230-09. — View Citation

Yang S, Guo X, Tien DR. Inferior Oblique Belly Transposition for Small Angle Hypertropia With Inferior Oblique Overaction: A Pilot Study. J Pediatr Ophthalmol Strabismus. 2018 Jan 1;55(1):43-46. doi: 10.3928/01913913-20170801-04. Epub 2017 Oct 9. — View Citation

Zhu W, Wang X, Jiang C, Ling L, Wu L, Zhao C. Effect of inferior oblique muscle belly transposition on versions and vertical alignment in primary position. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3461-3468. doi: 10.1007/s00417-021-05240-x. Epub 2021 Jun 18. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suboptimal surgical rate	Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.	at 12 months
Secondary	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