Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT)

Intermittent Exotropia Clinical Trial

Official title:

Pre and Post-operative Rectus Muscle Insertion Site Changing Using Anterior Segment Optical Coherence Tomography in Strabismus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383381
• Other study ID #: 2013-05-026-005
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: March 3, 2015
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

•Background and study aims : The investigators conducted this study to evaluate the movement of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.

• Who can participate? patients who underwent typical lateral rectus recession surgery for correcting intermittent exotropia

• What does the study involve? Volunteers will attend a clinic for four visits over six months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT.

• What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test.

• Where is the study run from? Samsung Medical Center

• When is the study starting and how long is it expected to run for? From Feb 2014 to Dec 2014

Description:

The aim of this study is 1) to evaluate the reliability and accuracy of AS-OCT in the measurement of the lateral rectus (LR) insertion distance, 2)to investigate the longitudinal change of LR muscle insertion after strabismus surgery, and 3)to determine the effect of insertion movement on the angle of deviation after strabismus surgery. An AS-OCT scan of the LR muscle was performed every visits. Preoperative limbus-LR insertion distance was compared with intraoperative surgical caliper measurement of LR insertion using intraclass correlation coefficient analysis (ICC). Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• patients who underwent lateral rectus recession surgery for correcting intermittent exotropia

Exclusion Criteria:

• previous ocular surgery

• other ocular diseases except intermittent exotropia

• amblyopia

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Exotropia

Intervention

Procedure:
• lateral rectus recession
typical surgery for correcting intermittent exotropia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (1)

Liu X, Wang F, Xiao Y, Ye X, Hou L. Measurement of the limbus-insertion distance in adult strabismus patients with anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Oct 28;52(11):8370-3. doi: 10.1167/iovs.11-7752. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of limbus-muscle insertion distance measured with AS-OCT		baseline and 1.3.6 months	No

External Links

•   basic information of intermittent exotropia including treatment