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 range

5 Years – 12 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

surgical successful rate

Timeframe: at 12 month

Trial details

NCT IDNCT04064112

SponsorChen Zhao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-19

View on ClinicalTrials.gov More Convergence Insufficiency Intermittent Exotropia (CI-IXT) trials