Status:
COMPLETED
S-BLR Versus C-BLR for CI-IXT in Children
Lead Sponsor:
Chen Zhao
Collaborating Sponsors:
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Convergence Insufficiency Intermittent Exotropia (CI-IXT)
Eligibility:
All Genders
5-12 years
Phase:
NA
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 sur...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04064112
Start Date
October 18 2019
End Date
February 11 2023
Last Update
December 20 2023
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, China