S-BLR Versus C-BLR for CI-IXT in Children (SCCIXT)

December 14, 2023 updated by: Chen Zhao

Slanted Bilateral Lateral Rectus Recession Versus Conventional Bilateral Lateral Rectus Recession for Convergence Insufficiency Intermittent Exotropia in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using conventional surgical procedures, higher postoperative near undercorrection and/or distant overcorrection rates were observed in CI-IXT. To achieve better outcome, S-BLR was introduced. Previous studies showed its efficacy in reducing near exodeviation, distant exodeviation, and NDD. So far, only limited studies have directly evaluated the surgical outcomes between S-BLR and C-BLR. The pilot study done by Snir et al included 12 patients with S-BLR and 6 patients with C-BLR and the success rates of S-BLR vs C-BLR were 92% vs 0 at one-year follow-up. The retrospective study done by Song et al included 17 patients undergoing S-BLR and 14 patients undergoing C-BLR. With stricter successful criteria, the success rates of S-BLR vs C-BLR were 35% vs 7% at six-month follow-up. A large randomized trial is needed to compare the surgical successful rate and suboptimal surgical outcomes of S-BLR with C-BLR in children with CI-IXT.

The proposed trial will be conducted in 6 different study sites working in the field of pediatric ophthalmology and strabismus.Each site will have one certified surgeon to do all surgeries. Under general anesthesia, the LR recession is performed using an inferior-temporal fornix incision. For S-BLR, the lower horn of the LR is recessed based on near exodeviation and the upper horn is recessed based on distant exodeviation. For C-BLR, the LR is recessed based on distant exodeviation. Surgical dose is according to the largest preoperative exodeviation at distance (6 meters) or near (1/3 meter) by the prism and alternate cover test(PACT). The extent of the recession is based on Parks' surgical dosage schedule.

Study Type

Interventional

Enrollment (Actual)

200

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 Locations

  • China
      • Shanghai, China
        • Eye & ENT Hospital of Fudan University

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

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Exodeviation at least 15 at distance (6 meters);
  • Exodeviation at most 50 at near (1/3 meter);
  • Greater exodeviation at near than at distance by 10 or more;
  • Control score of exodeviation greater than 3;
  • Best-corrected visual acuity of 20/40 or better in the worse eye, and interocular difference of less than 2 lines;
  • Myopia5.00D, hyperopia3.0D and anisometropia≤2.5D based on cycloplegic refraction
  • Optical correction needed for at least 2 weeks before evaluation of exodeviation: myopia0.5D or astigmatism1.5D in either eye, or anisometropia1.0D;
  • Written informed consent given by participants and their parents or legal guardians.

Exclusion Criteria:

  • Prior strabismus surgery or botulinum toxin injection;
  • Coexisting vertical deviation greater than 5, oblique muscle dysfunction, torsional deviation, dissociated vertical deviation, A-V pattern, or other conditions requiring horizontal rectus transposition, oblique surgery or vertical rectus surgery;
  • Paralytic or restrictive strabismus;
  • Lateral incomitance (greater exodeviation in right or left gaze position than in primary position by 5 or more with appropriate optical correction);
  • Ocular disease other than strabismus or refractive error;
  • Previous intraocular or refractive surgery;
  • Craniofacial malformations affecting the orbit;
  • Significant neurological disorders;
  • Birth date34 weeks or birth weight1500 gram.

Abbreviations: CI-IXT, convergence insufficiency intermittent exotropia; D, diopter.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-BLR
For S-BLR, the lower horn of the LR is recessed based on near exodeviation and the upper horn is recessed based on distant exodeviation.
Procedure: S-BLR
Surgery of slanted bilateral LR recession for CI-IXT patients
Active Comparator: C-BLR
For C-BLR, the LR is recessed based on distant exodeviation.
Procedure: C-BLR
Surgery of conventional bilateral lateral rectus recession for CI-IXT patients

What is the study measuring?

Primary 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 a postoperative residual deviation at near and distance between 10 PD of exophoria/tropia and 5 PD of esophoria/tropia with near-distance difference <10 PD.
at 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
suboptimal surgical rate
Time Frame: at 12 month
suboptimal surgical cases/total cases. Suboptimal surgical outcomes include: undercorrection, overcorrection, diplopia, torsional deviation, A-V pattern, abduction limitation and reoperation.
at 12 month

Collaborators and Investigators

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

Sponsor

Chen Zhao

Collaborators

Shanghai Jiao Tong University School of Medicine
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Renmin Hospital of Wuhan University
Tianjin Eye Hospital
AIER Eye Hospital (Kunming)

Investigators

  • Principal Investigator: Xiaoli Kang, Doctor, Xinhua Hospital, Shanghai Jiao Tong University
  • Principal Investigator: Yueping Li, Doctor, TianJin eye hospital
  • Principal Investigator: Lianhong Zhou, Doctor, Renmin Hospital of Wuhan University
  • Principal Investigator: Chenhao Yang, Doctor, Children's Hospital of Fudan University
  • Study Chair: Chen Zhao, Doctor, Eye & ENT Hospital of Fudan University
  • Study Director: Jing Yao, Doctor, Eye & ENT Hospital of Fudan University
  • Principal Investigator: Jiangtao Xu, Doctor, AIER Eye Hospital (Kunming)

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)

October 18, 2019

Primary Completion (Actual)

February 19, 2022

Study Completion (Actual)

February 11, 2023

Study Registration Dates

First Submitted

August 4, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019C-PEDIG

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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