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

NCT04064112 | Completed DMC

• 1 other identifier: 2019C-PEDIG
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• surgical successful rate

  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 Outcomes (1)

• suboptimal surgical rate

  at 12 month

Study Arms (2)

S-BLR

EXPERIMENTAL

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

C-BLR

ACTIVE COMPARATOR

For C-BLR, the LR is recessed based on distant exodeviation.

Procedure: C-BLR

Interventions

S-BLR PROCEDURE

Surgery of slanted bilateral LR recession for CI-IXT patients

S-BLR

C-BLR PROCEDURE

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

C-BLR

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Zhao: lead
• Children's Hospital of Fudan University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Tianjin Eye Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• AIER Eye Hospital (Kunming): collaborator

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Related Publications (12)

• Burian HM. Exodeviations: their classification, diagnosis and treatment. Am J Ophthalmol. 1966 Dec;62(6):1161-6. doi: 10.1016/0002-9394(66)92570-0. No abstract available.

  PMID: 5957892 BACKGROUND

• Raab EL, Parks MM. Recession of the lateral recti. Effect of Preoperative fusion and distance-near relationship. Arch Ophthalmol. 1975 Aug;93(8):584-6. doi: 10.1001/archopht.1975.01010020568002.

  PMID: 1156220 BACKGROUND

• Snir M, Axer-Siegel R, Shalev B, Sherf I, Yassur Y. Slanted lateral rectus recession for exotropia with convergence weakness. Ophthalmology. 1999 May;106(5):992-6. doi: 10.1016/S0161-6420(99)00522-9.

  PMID: 10328402 BACKGROUND

• Chun BY, Kang KM. Early results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence insufficiency. J Ophthalmol. 2015;2015:380467. doi: 10.1155/2015/380467. Epub 2015 Jan 26.

  PMID: 25688298 BACKGROUND

• Farid MF, Abdelbaset EA. Surgical outcomes of three different surgical techniques for treatment of convergence insufficiency intermittent exotropia. Eye (Lond). 2018 Apr;32(4):693-700. doi: 10.1038/eye.2017.259. Epub 2017 Dec 22.

  PMID: 29271419 BACKGROUND

• Chen X, Fu Z, Yu J, Ding H, Bai J, Chen J, Gong Y, Zhu H, Yu R, Liu H. Prevalence of amblyopia and strabismus in Eastern China: results from screening of preschool children aged 36-72 months. Br J Ophthalmol. 2016 Apr;100(4):515-9. doi: 10.1136/bjophthalmol-2015-306999. Epub 2015 Aug 10.

  PMID: 26261229 BACKGROUND

• Yang HK, Hwang JM. Surgical outcomes in convergence insufficiency-type exotropia. Ophthalmology. 2011 Aug;118(8):1512-7. doi: 10.1016/j.ophtha.2011.01.004. Epub 2011 Apr 7.

  PMID: 21474185 BACKGROUND

• Wang B, Wang L, Wang Q, Ren M. Comparison of different surgery procedures for convergence insufficiency-type intermittent exotropia in children. Br J Ophthalmol. 2014 Oct;98(10):1409-13. doi: 10.1136/bjophthalmol-2013-304442. Epub 2014 May 19.

  PMID: 24842862 BACKGROUND

• Ma L, Yang L, Li N. Bilateral lateral rectus muscle recession for the convergence insufficiency type of intermittent exotropia. J AAPOS. 2016 Jun;20(3):194-196.e1. doi: 10.1016/j.jaapos.2016.01.014. Epub 2016 May 6.

  PMID: 27164428 BACKGROUND

• Choi DG, Rosenbaum AL. Medial rectus resection(s) with adjustable suture for intermittent exotropia of the convergence insufficiency type. J AAPOS. 2001 Feb;5(1):13-7. doi: 10.1067/mpa.2001.111137.

  PMID: 11182666 BACKGROUND

• BURIAN HM, SPIVEY BE. THE SURGICAL MANAGEMENT OF EXODEVIATIONS. Am J Ophthalmol. 1965 Apr;59:603-20. No abstract available.

  PMID: 14270998 BACKGROUND

• Kraft SP, Levin AV, Enzenauer RW. Unilateral surgery for exotropia with convergence weakness. J Pediatr Ophthalmol Strabismus. 1995 May-Jun;32(3):183-7. doi: 10.3928/0191-3913-19950501-12.

  PMID: 7636700 BACKGROUND

Study Officials

• Chen Zhao, Doctor

  Eye & ENT Hospital of Fudan University

  STUDY CHAIR

• 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

• Jing Yao, Doctor

  Eye & ENT Hospital of Fudan University

  STUDY DIRECTOR

• Chenhao Yang, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Jiangtao Xu, Doctor

  AIER Eye Hospital (Kunming)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Department of Ophthalmology and Visual Science

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 21, 2019
• Study Start: October 18, 2019
• Primary Completion: February 19, 2022
• Study Completion: February 11, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)