Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

Exotropia Clinical Trial

— XT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05643456
• Other study ID #: RIO
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Exotropia

Intervention

Procedure:
• surgery
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.

Locations

Country	Name	City	State
Egypt	Reham fawzy elsherbiny	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alignment in the primary position	measuring any misalignment by prism bar	1 week to 6 months
Primary	palpebral fissure height	measuring with millimeter	1 week to 6 months
Primary	End gaze deficit	measuring with prism bar	1 week to 6 months