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Search / Trial NCT04064112

S-BLR Versus C-BLR for CI-IXT in Children

Launched by CHEN ZHAO · Aug 19, 2019

Trial Information

Current as of July 04, 2025

Completed

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

  • 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; D, diopter.

About Chen Zhao

Chen Zhao is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and treatments, Chen Zhao collaborates with leading researchers and healthcare institutions to design and execute rigorous clinical studies. The organization prioritizes ethical standards, patient safety, and regulatory compliance, ensuring that all trials are conducted with integrity and transparency. Through its strategic partnerships and cutting-edge methodologies, Chen Zhao aims to contribute valuable insights to the medical community and facilitate the development of effective healthcare solutions.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

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

Lianhong Zhou, Doctor

Principal Investigator

Renmin Hospital of Wuhan University

Jing Yao, Doctor

Study Director

Eye & ENT Hospital of Fudan University

Chenhao Yang, Doctor

Principal Investigator

Children's Hospital of Fudan University

Jiangtao Xu, Doctor

Principal Investigator

AIER Eye Hospital (Kunming)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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