HypertropiaNCT05415553
IOBT Versus IO-Rec for Hypertropia With IOOA (IIHIOOA)
A study testing IOBT and IO-Rec in people with Hypertropia and Inferior Oblique Overaction, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Hypertropia, Inferior Oblique Overaction
- What is being tested?
- IOBT and IO-Rec
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Wenqing Zhu contact
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
Wenqing Zhu, Doctor
About this study
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
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.
Read the 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.
- Conditions
- Hypertropia, Inferior Oblique Overaction
- Being tested
- IOBT, IO-Rec
- Keywords
- Inferior oblique muscle belly transposition, Inferior oblique muscle recession, Inferior oblique overaction
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOBTProcedure or surgery
Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction
IO-RecProcedure or surgery
Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction
| Study group | Role | What they receive |
|---|---|---|
| IOBT group | Experimental | 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. Receives: Procedure: IOBT |
| IO-Rec group | Active comparator | 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. Receives: Procedure: IO-Rec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suboptimal surgical rate
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
Measured: at 12 months
Secondary outcomes (1)
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.
Measured: at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertropiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415553
- Sponsor's protocol ID
- 2022-IOBT
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We concerns about patient privacy issues and it's better to protect the publication potential.
Publications
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.
PubMed 23203704Alajbegovic-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.
PubMed 26261384Nabie 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.
PubMed 31844794Akbari 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.
PubMed 30371917Hendler 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.
PubMed 23143910Bhatta 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.
PubMed 21323243Yang 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.
PubMed 28991348Zhu 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.
PubMed 34142185Tomarchio 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.
PubMed 25643372Kasem 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.
PubMed 32462341Shipman 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.
PubMed 14704751
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05415553
- Acronym / sponsor ID
- 2022-IOBT
- Conditions
- Hypertropia, Inferior Oblique Overaction
- Keywords
- Inferior oblique muscle belly transposition, Inferior oblique muscle recession, Inferior oblique overaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- 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
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOBT group | Experimental | Procedure: IOBTFor IOBT, the whole belly of inferior oblique muscle is anchored to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle. |
| IO-Rec group | Active comparator | Procedure: IO-RecFor 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 4 years at the time of surgery;
- Vertical deviation (VD) in primary position (5△ ≤ VD ≤ 10△)
- IOOA for three following situations:
- Without amblyopia
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOBTSurgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction | Procedure or surgery | IOBT group |
| IO-RecSurgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction | Procedure or surgery | IO-Rec group |
Primary outcome
Suboptimal surgical rate
Time frame: at 12 months
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
1 secondary outcome
Surgical successful rate
Time frame: at 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 23203704Bahl 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.
- Background: PubMed 26261384Alajbegovic-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.
- Background: PubMed 31844794Nabie 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.
- Background: PubMed 30371917Akbari 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.
- Background: PubMed 23143910Hendler 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.
- Background: PubMed 21323243Bhatta 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.
- Background: PubMed 28991348Yang 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.
- Background: PubMed 34142185Zhu 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.
- Background: PubMed 25643372Tomarchio 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.
- Background: PubMed 32462341Kasem 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.
- Background: PubMed 14704751Shipman 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.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it's better to protect the publication potential.
Related trials for Hypertropia
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Botulinum Toxin for Strabismus Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenqing Zhu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOBT and IO-Rec in people with Hypertropia and Inferior Oblique Overaction, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Zhao (+86-021-6437-7134, dr_zhaochen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suboptimal surgical rate (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415553, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.