Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

NCT05643456 | Completed DMC

• 1 other identifier: RIO
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Exotropia

Outcome Measures

Primary Outcomes (3)

• alignment in the primary position

  measuring any misalignment by prism bar

  1 week to 6 months

• palpebral fissure height

  measuring with millimeter

  1 week to 6 months

• End gaze deficit

  measuring with prism bar

  1 week to 6 months

Study Arms (2)

group 1 :Two muscle surgery

ACTIVE COMPARATOR

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

Procedure: surgery

group 2:Three muscle surgery

ACTIVE COMPARATOR

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

Procedure: surgery

Interventions

surgery PROCEDURE

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.

group 1 :Two muscle surgery; group 2:Three muscle surgery

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Angle of deviation less than 40 PD or more than 55 PD.
• History of previous surgery.
• Inconcomitant exotropia.
• Incomitance in any gaze.
• Associated vertical deviation(oblique dysfunction,A or V pattern).
• Patients with neurological deficit.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Reham fawzy elsherbiny

Giza, 0000, Egypt

Location

MeSH Terms

Conditions

Exotropia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Lobna MH Khazbm, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

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

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 8, 2022
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

EG (1)