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

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ClinicalTrials.gov Identifier: NCT02383381
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief 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

Condition or disease Intervention/treatment
Intermittent Exotropia Procedure: lateral rectus recession

Detailed 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pre and Post-operative Rectus Muscle Insertion Site Changing Using Anterior Segment Optical Coherence Tomography in Strabismus Patients
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

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


Primary Outcome Measures :
  1. The change of limbus-muscle insertion distance measured with AS-OCT [ Time Frame: baseline and 1.3.6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients : 21 males and 9 females age: 9 to 60 years
Criteria

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
Additional Information:
Publications:
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02383381    
Other Study ID Numbers: 2013-05-026-005
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: February 2014
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases