S-BLR Versus C-BLR for CI-IXT in Children (NCT04064112) | Clinical Trial Compass
CompletedNot Applicable
S-BLR Versus C-BLR for CI-IXT in Children
China200 participantsStarted 2019-10-18
Plain-language 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.
Who can participate
Age range5 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…