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NCT Number: NCT02383381

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

•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

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Key information

Conditions

Intermittent Exotropia

Age range

9 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral rectus recession

Procedure

typical surgery for correcting intermittent exotropia

Primary outcomes

  1. The change of limbus-muscle insertion distance measured with AS-OCT

    Time frame: baseline and 1.3.6 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 9, 2015
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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