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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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.
Surery of conventional bilateral lateral rectus recession for CI-IXT patients
- 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.
- 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.
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
|Contact: Chen Zhao, Doctoremail@example.com|
|Contact: Jing Yao, Doctorfirstname.lastname@example.org|
|Eye & ENT Hospital of Fudan University||Recruiting|
|Contact: Jing Yao, Doctor|
|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|