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Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT) in Two Recession Surgeries (AS-OCT)

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ClinicalTrials.gov Identifier: NCT02450162
Recruitment Status : Unknown
Verified April 2015 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
  • Background and study aims : The investigators conducted this study to compare the movement of extraocular muscle after two types of recession surgery with non-invasive tool called AS-OCT.
  • Who can participate? patients who will undergo two types (conventional method and hang-back method) of typical bilateral lateral rectus recession surgery for correcting intermittent exotropia
  • What does the study involve? Volunteers will attend a clinic for four visits over three 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 April 2015 to Dec 2015

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

Detailed Description:
This study is a following study of our prior study about AS-OCT in strabismus. The aim of this study is to compare the longitudinal changes of lateral rectus (LR) muscle insertion between two types of bilateral recession surgery. An AS-OCT scan of the LR muscle was performed every visits. Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 in each group.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Changes of Lateral Rectus Muscle Insertion Measured With AS-OCT in Two Recession Surgeries
Study Start Date : May 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Group/Cohort Intervention/treatment
conventional lateral rectus recession
This is the standard technique for recession with two single-armed sutures.Exposure of the rectus muscle insertion includes freeing the insertion and proximal muscle borders sufficiently to place the sutures. And the needle is passed through the tendon avoiding the anterior ciliary arteries. If the sutures are passed as shown a true knot is formed, and the muscle is detached. Then a caliper measures from the limbus or the original insertion. A passage of the needle through sclera. The recessed muscle is ideally parallel to the old insertion (or nearly so). Conjunctival incision was finally sutured.
Procedure: lateral rectus recession (bilateral)
Two types of recession (conventional or hang-back method) are typical surgeries for correcting intermittent exotropia. It depends on surgeon's decision at the time of surgery.

hang-back lateral rectus recession
The hang-back recession has been described as "a simple, safe alternative to conventional recession." The procedure is said to be less likely to result in scleral perforation because needles are placed through relatively thicker sclera near the insertion site. It is the modified techique for recession with one double-armed sutures.
Procedure: lateral rectus recession (bilateral)
Two types of recession (conventional or hang-back method) are typical surgeries for correcting intermittent exotropia. It depends on surgeon's decision at the time of surgery.




Primary Outcome Measures :
  1. The change of limbus-muscle insertion distance measured with AS-OCT [ Time Frame: baseline and 1.3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

60 patients

: 30 for conventional recession surgery 30 for hang-back recession surgery

Criteria

Inclusion Criteria:

  • patients who will undergo bilateral lateral rectus recession surgery for correcting intermittent exotropia

Exclusion Criteria:

  • previous ocular surgery
  • other ocular diseases except intermittent exotropia
  • amblyopia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450162


Contacts
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Contact: Sei Yeul Oh 821031115293

Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02450162    
Other Study ID Numbers: 2015-02-115
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases