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

July 28, 2022 updated by: Eye & ENT Hospital of Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wenqing Zhu

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Eye & ENT Hospital of Fudan University
        • Contact:
          • Wenqing Zhu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IOBT group
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
Surgery of inferior oblique muscle belly transposition for treatment of primary position hypertropia with inferior oblique overaction
Active Comparator: IO-Rec group
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 recession for treatment of primary position hypertropia with inferior oblique overaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suboptimal surgical rate
Time Frame: at 12 months
Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical successful rate
Time Frame: at 12 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-IOBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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