S-BLR Versus C-BLR for CI-IXT in Children

Summary

This is a multi-center, randomized single-blind controlled trial to compare the effectiveness of S-BLR with C-BLR for the treatment of CI-IXT in children.

Specific Aim 1 (Primary): To compare the surgical successful rate of S-BLR with C-BLR for the treatment of CI-IXT in children.

Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between S-BLR and C-BLR for the treatment of CI-IXT in children.

Conditions

• Convergence Insufficiency Intermittent Exotropia (CI-IXT)

Interventions

PROCEDURE

S-BLR

Surgery of slanted bilateral LR recession for CI-IXT patients

PROCEDURE

C-BLR

Surgery of conventional bilateral lateral rectus recession for CI-IXT patients

Sponsors & Collaborators

• Children's Hospital of Fudan University

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Tianjin Eye Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• AIER Eye Hospital (Kunming)

  collaborator UNKNOWN

• Chen Zhao

  lead OTHER

Principal Investigators

• Chen Zhao, Doctor · Eye & ENT Hospital of Fudan University

• Xiaoli Kang, Doctor · Xinhua Hospital, Shanghai Jiao Tong University

• Yueping Li, Doctor · Tianjin Eye Hospital

• Lianhong Zhou, Doctor · Renmin Hospital of Wuhan University

• Jing Yao, Doctor · Eye & ENT Hospital of Fudan University

• Chenhao Yang, Doctor · Children's Hospital of Fudan University

• Jiangtao Xu, Doctor · AIER Eye Hospital (Kunming)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-18

Primary Completion

2022-02-19

Completion

2023-02-11

Countries

• China

Study Locations