Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness

Intermittent Exotropia Clinical Trial

Official title:

Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131792
• Other study ID #: KNUH2014-02
• Status: Completed
• Phase: N/A
• First received: May 4, 2014
• Last updated: May 4, 2014
• Start date: June 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

Description:

This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more

• Patients with follow up duration greater than 6 months

Exclusion Criteria:

• Patients with previous ocular or strabismus surgery

• Patients with ocular or neurologic pathologic conditions

• Follow up duration less than 6 months

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Procedure:
• Slanted recession of the lateral rectus muscle
All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.

Locations

Country	Name	City	State
Korea, Republic of	Bo Young Chun	Daegu	Kyungsangpookdo

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.	Measurement of deviation angle after slanted recession surgery was performed.	preop, 6months postop	No
Secondary	Changes from baseline of near-distance difference after slanted recession surgery at 6 months	Measurement of stereopsis after slanted recession was performed.	preop, 6 months postop	No