Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-10-18
2023-02-11
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
S-BLR
Surgery of slanted bilateral LR recession for CI-IXT patients
C-BLR
For C-BLR, the LR is recessed based on distant exodeviation.
C-BLR
Surgery of conventional bilateral lateral rectus recession for CI-IXT patients
Interventions
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S-BLR
Surgery of slanted bilateral LR recession for CI-IXT patients
C-BLR
Surgery of conventional bilateral lateral rectus recession for CI-IXT patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
12 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Tianjin Eye Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
AIER Eye Hospital (Kunming)
UNKNOWN
Chen Zhao
OTHER
Responsible Party
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Chen Zhao
Vice President of Department of Ophthalmology and Visual Science
Principal Investigators
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Chen Zhao, Doctor
Role: STUDY_CHAIR
Eye & ENT Hospital of Fudan University
Xiaoli Kang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University
Yueping Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tianjin Eye Hospital
Lianhong Zhou, Doctor
Role: PRINCIPAL_INVESTIGATOR
Renmin Hospital of Wuhan University
Jing Yao, Doctor
Role: STUDY_DIRECTOR
Eye & ENT Hospital of Fudan University
Chenhao Yang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Jiangtao Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
AIER Eye Hospital (Kunming)
Locations
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Eye & ENT Hospital of Fudan University
Shanghai, , China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
BURIAN HM, SPIVEY BE. THE SURGICAL MANAGEMENT OF EXODEVIATIONS. Am J Ophthalmol. 1965 Apr;59:603-20. No abstract available.
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.
Other Identifiers
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2019C-PEDIG
Identifier Type: -
Identifier Source: org_study_id