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

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ClinicalTrials.gov Identifier: NCT04064112
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Children's Hospital of Fudan University
Shandong Provincial Hospital
Shanxi Eye Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tianjin Eye Hospital
Renmin Hospital of Wuhan University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
Chen Zhao, Eye & ENT Hospital of Fudan University

Brief Summary:

This is a multi-center, randomized double-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.


Condition or disease Intervention/treatment Phase
Convergence Insufficiency Intermittent Exotropia (CI-IXT) Procedure: S-BLR Procedure: C-BLR Not Applicable

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 8 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Slanted Bilateral Lateral Rectus Recession Versus Conventional Bilateral Lateral Rectus Recession for Convergence Insufficiency Intermittent Exotropia in Children
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : December 22, 2021

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CI-IXT (at least 15 PD of exodeviation at distance by the prism and alternate cover test (PACT) with appropriate optical correction; ≥10 PD greater exodeviation at near than at distance after 40-minute monocular patching);
  • age from 5 to 12 years at the time of surgery;
  • best-corrected visual acuity (BCVA) in the worse eye 20/40 or better and interocular visual acuity difference of less than 2 lines;

Exclusion Criteria:

  • with histories of strabismus surgery or botulinum toxin injection;
  • coexisting vertical deviation greater than 5PD (oblique muscle dysfunction; torsional strabismus; DVD; A-V pattern);
  • restrictive or paralytic strabismus;
  • lateral incomitance;
  • ocular disease other than strabismus or refractive error;
  • craniofacial malformations affecting the orbits;
  • significant neurological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064112


Contacts
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Contact: Chen Zhao, Doctor +8618917785656 dr_zhaochen@163.com
Contact: Jing Yao, Doctor 15900791046 yaojingxiao@163.com

Locations
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China
Eye & ENT Hospital of Fudan University Recruiting
Shanghai, China
Contact: Jing Yao, Doctor         
Sponsors and Collaborators
Chen Zhao
Children's Hospital of Fudan University
Shandong Provincial Hospital
Shanxi Eye Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tianjin Eye Hospital
Renmin Hospital of Wuhan University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Chen Zhan, Doctor Eye & ENT Hospital of Fudan University
Principal Investigator: Lihua Wang, Doctor Shandong Provincial Hospital
Principal Investigator: Junhong Li, Doctor Shanxi Eye Hospital
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: Zhaohui Sun, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang Uniersity
Principal Investigator: Jing Yao, Doctor Eye & ENT Hospital of Fudan University
Study Director: Chen Zhao, Doctor Eye & ENT Hospital of Fudan University
Principal Investigator: Chenhao Yang, Doctor Children's Hospital of Fudan University
Publications:

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Responsible Party: Chen Zhao, Vice President of Department of Ophthalmology and Visual Science, Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04064112    
Other Study ID Numbers: 2019C-PEDIG
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We concerns about patient privacy issues and it's better to protect the publication potential.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exotropia
Ocular Motility Disorders
Strabismus
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Central Nervous System Diseases