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Not yet recruiting NCT07143032

A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia

No phase Interventional Exotropia Equal or More Than 50 Prism Diopter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extropia squint surgery.
Who it may be relevant to
Registry conditions: Exotropia Equal or More Than 50 Prism Diopter. Basic parameters: 3 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia: Bilateral Lateral Rectus Recession With Medial Rectus Resection, Bilateral Medial Rectus Resection and Resection-Transplantation

Overview

This is a randomized comparative interventional study that aims to compare the surgical outcomes of correcting large angle exotropia (≥50 prism diopter) by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation,

Detailed description

This is a randomized comparative interventional study that will be conducted on patients with large angle exotropia before and after doing surgical correction using three different surgical techniques including : 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.

Interventions

  • Procedure Extropia squint surgery
    patients with large angle exotropia will be treated by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.

Primary outcome measures

  • changes in ocular alignment [Time frame: at one month, 6 month and one year postoperatively.]

Eligibility criteria

Inclusion criteria

  • Patients with large-angle exotropia (≥50 prism diopter).

Exclusion criteria

  • Patients with an exodeviation angle of less than 50 prism diopter.
  • History of previous strabismus surgery.
  • Restrictive or paretic strabismus or history of botulinum toxin injections for strabismus.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Cifuentes DL, Pineles SL, Demer JL, Velez FG. Surgical success and lateral incomitance following three-muscle surgery for large-angle horizontal strabismus. J AAPOS. 2018 Feb;22(1):17-21. doi: 10.1016/j.jaapos.2017.10.005. Epub 2017 Dec 1. PMID 29199031
  • Talebnejad MR, Johari MK, Khalili MR, Zare M. Supramaximal Recession and Resection Surgery in Large-Angle Strabismus: Outcomes of Large Interventional Case Series Exotropia and Esotropia. J Curr Ophthalmol. 2020 Mar 23;32(1):82-87. doi: 10.4103/JOCO.JOCO_22_20. eCollection 2020 Jan-Mar. PMID 32510018
  • Peters ER, Archer SM. Long-standing, large-angle exotropia in adults. Am Orthopt J. 2007;57:104-6. doi: 10.3368/aoj.57.1.104. PMID 21149163

Identifiers

NCT: NCT07143032 · Soh-Med-25-7-4MD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗