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

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.

Conditions

• Hypertropia
• Inferior Oblique Overaction

Interventions

PROCEDURE

IOBT

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

PROCEDURE

IO-Rec

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

Sponsors & Collaborators

• Children's Hospital of Fudan University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Shanxi Eye Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Tianjin Eye Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Xiamen Eye Center of Xiamen University

  collaborator UNKNOWN

• Kunming Aier Eye Hospital

  collaborator UNKNOWN

• Eye & ENT Hospital of Fudan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• China

Study Locations