NCT05415553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 29, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

June 9, 2022

Last Update Submit

July 28, 2022

Conditions

HypertropiaInferior Oblique Overaction

Keywords

Inferior oblique muscle belly transpositionInferior oblique muscle recessionInferior oblique overaction

Outcome Measures

Primary Outcomes (1)

  • Suboptimal surgical rate

    Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.

    at 12 months

Secondary Outcomes (1)

  • Surgical successful rate

    at 12 month

Study Arms (2)

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.

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.

Procedure: IO-Rec

Interventions

IOBTPROCEDURE

Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction

IOBT group
IO-RecPROCEDURE

Surgery of inferior oblique muscle recession for treatment of primary position hypertropia with inferior oblique overaction

IO-Rec group

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 23203704BACKGROUND

  • 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.

    PMID: 26261384BACKGROUND

  • 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.

    PMID: 31844794BACKGROUND

  • 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.

    PMID: 30371917BACKGROUND

  • 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.

    PMID: 23143910BACKGROUND

  • 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.

    PMID: 21323243BACKGROUND

  • 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.

    PMID: 28991348BACKGROUND

  • 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.

    PMID: 34142185BACKGROUND

  • 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.

    PMID: 25643372BACKGROUND

  • 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.

    PMID: 32462341BACKGROUND

  • 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.

    PMID: 14704751BACKGROUND

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Central Study Contacts

Chen Zhao

CONTACT

+86-021-6437-7134dr_zhaochen@163.com

Wenqing Zhu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 13, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

We concerns about patient privacy issues and it's better to protect the publication potential.

Locations

CN(1)