A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia

NCT ID: NCT07143032

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Exotropia Equal or More Than 50 Prism Diopter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection

patients with large angle exotropia treated by bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection

Group Type ACTIVE_COMPARATOR

Extropia squint surgery

Intervention Type PROCEDURE

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.

bilateral medial rectus muscle resection

patients with large angle exotropia treated by bilateral medial rectus muscle resection

Group Type ACTIVE_COMPARATOR

Extropia squint surgery

Intervention Type PROCEDURE

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.

unilateral medial rectus muscle resection with lateral rectus muscle transplantation

patients with large angle exotropia treated by unilateral medial rectus muscle resection with lateral rectus muscle transplantation

Group Type ACTIVE_COMPARATOR

Extropia squint surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with an exodeviation angle of less than 50 prism diopter.
2. History of previous strabismus surgery.
3. Restrictive or paretic strabismus or history of botulinum toxin injections for strabismus.
Minimum Eligible Age

3 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Sara Ahmed Abdelraheem

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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sara ahmed abdelraheem, Assistant lecturer

Role: CONTACT

+201153987387

Alahmady Hamad Alsaman, Professor

Role: CONTACT

+201111102698

References

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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.

Reference Type BACKGROUND
PMID: 29199031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32510018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21149163 (View on PubMed)

Other Identifiers

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Soh-Med-25-7-4MD

Identifier Type: -

Identifier Source: org_study_id

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