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CompletedNCT05643456XTUpdated Dec 8, 2022

Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

An interventional study of surgery in Exotropia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study summary

Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia

Read the detailed description

Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).

02

Conditions studied

  • Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 69 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.

Exclusion criteria

Exclusion Criteria:

  1. Angle of deviation less than 40 PD or more than 55 PD.
  2. History of previous surgery.
  3. Inconcomitant exotropia.
  4. Incomitance in any gaze.
  5. Associated vertical deviation(oblique dysfunction,A or V pattern).
  6. Patients with neurological deficit.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    group 1 :Two muscle surgery

    30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)

    Procedure: surgery

  • Active comparator
    group 2:Three muscle surgery

    39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)

    Procedure: surgery

Interventions

  • Proceduresurgery

    69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession. The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.

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What researchers measure

Primary outcomes

  1. alignment in the primary position

    measuring any misalignment by prism bar

    Time frame: 1 week to 6 months

  2. palpebral fissure height

    measuring with millimeter

    Time frame: 1 week to 6 months

  3. End gaze deficit

    measuring with prism bar

    Time frame: 1 week to 6 months

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Study locations

1 site
  • Reham fawzy elsherbiny
    Giza, 0000, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05643456
Lead sponsor
Cairo University
Responsible party
reham fawzy elsherbiny (assisstant lecturer, Cairo University) — Principal investigator
First posted
Dec 8, 2022
Start date
Jul 1, 2020
Primary completion
Dec 1, 2020
Completion
Dec 30, 2021
Last update
Dec 8, 2022

Study contacts

Lobna MH Khazbm, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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