Convergence Insufficiency Intermittent Exotropia (CI-IXT)SCCIXTNCT04064112
S-BLR Versus C-BLR for CI-IXT in Children
A study testing S-BLR and C-BLR in people with Convergence Insufficiency Intermittent Exotropia (CI-IXT), run by Chen Zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Convergence Insufficiency Intermittent Exotropia (CI-IXT)
- What is being tested?
- S-BLR and C-BLR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2019to 11 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- Craniofacial malformations affecting the orbit;
- Significant neurological disorders;
- Birth date34 weeks or birth weight1500 gram.
- Abbreviations: CI-IXT, convergence insufficiency intermittent exotropia; D, diopter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- S-BLR, C-BLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-BLRProcedure or surgery
Surgery of slanted bilateral LR recession for CI-IXT patients
C-BLRProcedure or surgery
Surgery of conventional bilateral lateral rectus recession for CI-IXT patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: S-BLR |
| C-BLR | Active comparator | For C-BLR, the LR is recessed based on distant exodeviation. Receives: Procedure: C-BLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 month
Secondary outcomes (1)
suboptimal surgical rate
suboptimal surgical cases/total cases. Suboptimal surgical outcomes include: undercorrection, overcorrection, diplopia, torsional deviation, A-V pattern, abduction limitation and reoperation.
Measured: at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start18 Oct 2019
- Primary completion19 Feb 2022
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Convergence Insufficiency Intermittent Exotropia (CI-IXT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital, Renmin Hospital of Wuhan University, AIER Eye Hospital (Kunming)
- Responsible party
- Sponsor-investigator, Chen Zhao, Eye & ENT Hospital of Fudan University
- Investigators
- Chen Zhao, Doctor, Study chair, Eye & ENT Hospital of Fudan UniversityXiaoli Kang, Doctor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong UniversityYueping Li, Doctor, Principal investigator, Tianjin Eye HospitalLianhong Zhou, Doctor, Principal investigator, Renmin Hospital of Wuhan UniversityJing Yao, Doctor, Study director, Eye & ENT Hospital of Fudan UniversityChenhao Yang, Doctor, Principal investigator, Children's Hospital of Fudan UniversityJiangtao Xu, Doctor, Principal investigator, AIER Eye Hospital (Kunming)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064112
- Sponsor's protocol ID
- 2019C-PEDIG
- Acronym
- SCCIXT
- Status last verified
- Dec 2023
- First submitted
- 4 Aug 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We concerns about patient privacy issues and it's better to protect the publication potential.
Publications
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.
PubMed 5957892Raab 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.
PubMed 1156220Snir 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.
PubMed 10328402Chun 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.
PubMed 25688298Farid 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.
PubMed 29271419Chen 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.
PubMed 26261229Yang 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.
PubMed 21474185Wang 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.
PubMed 24842862Ma 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.
PubMed 27164428Choi 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.
PubMed 11182666BURIAN HM, SPIVEY BE. THE SURGICAL MANAGEMENT OF EXODEVIATIONS. Am J Ophthalmol. 1965 Apr;59:603-20. No abstract available.
PubMed 14270998Kraft 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.
PubMed 7636700
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slanted Bilateral Lateral Rectus Recession Versus Conventional Bilateral Lateral Rectus Recession for Convergence Insufficiency Intermittent Exotropia in Children
- ClinicalTrials.gov ID
- NCT04064112
- Acronym / sponsor ID
- SCCIXT / 2019C-PEDIG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chen ZhaoUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine, Tianjin Eye Hospital, Renmin Hospital of Wuhan University, AIER Eye Hospital (Kunming)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-BLR | Experimental | Procedure: S-BLRFor S-BLR, the lower horn of the LR is recessed based on near exodeviation and the upper horn is recessed based on distant exodeviation. |
| C-BLR | Active comparator | Procedure: C-BLRFor C-BLR, the LR is recessed based on distant exodeviation. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-BLRSurgery of slanted bilateral LR recession for CI-IXT patients | Procedure or surgery | S-BLR |
| C-BLRSurgery of conventional bilateral lateral rectus recession for CI-IXT patients | Procedure or surgery | C-BLR |
Primary outcome
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.
1 secondary outcome
suboptimal surgical rate
Time frame: at 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 5957892Burian 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.
- Background: PubMed 1156220Raab 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.
- Background: PubMed 10328402Snir 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.
- Background: PubMed 25688298Chun 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.
- Background: PubMed 29271419Farid 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.
- Background: PubMed 26261229Chen 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.
- Background: PubMed 21474185Yang 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.
- Background: PubMed 24842862Wang 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.
- Background: PubMed 27164428Ma 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.
- Background: PubMed 11182666Choi 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.
- Background: PubMed 14270998BURIAN HM, SPIVEY BE. THE SURGICAL MANAGEMENT OF EXODEVIATIONS. Am J Ophthalmol. 1965 Apr;59:603-20. No abstract available.
- Background: PubMed 7636700Kraft 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.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it's better to protect the publication potential.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Zhao, Doctor study chair
Eye & ENT Hospital of Fudan University
Xiaoli Kang, Doctor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University
Yueping Li, Doctor principal investigator
Tianjin Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-BLR and C-BLR in people with Convergence Insufficiency Intermittent Exotropia (CI-IXT), run by Chen Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical successful rate (time frame: at 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064112, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.