IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)
Primary Purpose
Hypertropia, Inferior Oblique Overaction
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IOBT
IO-Rec
Sponsored by
About this trial
This is an interventional treatment trial for Hypertropia focused on measuring Inferior oblique muscle belly transposition, Inferior oblique muscle recession, Inferior oblique overaction
Eligibility 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:
- 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
Sites / Locations
- Eye & ENT Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IOBT group
IO-Rec group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Suboptimal surgical rate
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05415553
First Posted
June 9, 2022
Last Updated
July 28, 2022
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Children's Hospital of Fudan University, Shandong Provincial Hospital, Shanxi Eye Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital, Renmin Hospital of Wuhan University, Xiamen Eye Center of Xiamen University, Kunming Aier Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05415553
Brief Title
IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Children's Hospital of Fudan University, Shandong Provincial Hospital, Shanxi Eye Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital, Renmin Hospital of Wuhan University, Xiamen Eye Center of Xiamen University, Kunming Aier Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertropia, Inferior Oblique Overaction
Keywords
Inferior oblique muscle belly transposition, Inferior oblique muscle recession, Inferior oblique overaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IOBT group
Arm Type
Experimental
Arm Description
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.
Arm Title
IO-Rec group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
IOBT
Intervention Description
Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction
Intervention Type
Procedure
Intervention Name(s)
IO-Rec
Intervention Description
Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction
Primary Outcome Measure Information:
Title
Suboptimal surgical rate
Description
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Surgical successful rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Zhao
Phone
+86-021-6437-7134
Email
dr_zhaochen@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenqing Zhu
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqing Zhu, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We concerns about patient privacy issues and it's better to protect the publication potential.
Citations:
PubMed Identifier
23203704
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.
Results Reference
background
PubMed Identifier
26261384
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.
Results Reference
background
PubMed Identifier
31844794
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.
Results Reference
background
PubMed Identifier
30371917
Citation
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.
Results Reference
background
PubMed Identifier
23143910
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.
Results Reference
background
PubMed Identifier
21323243
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.
Results Reference
background
PubMed Identifier
28991348
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.
Results Reference
background
PubMed Identifier
34142185
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.
Results Reference
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PubMed Identifier
25643372
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.
Results Reference
background
PubMed Identifier
32462341
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.
Results Reference
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PubMed Identifier
14704751
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. doi: 10.1038/sj.eye.6700488.
Results Reference
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IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)
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