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

NCT02450162 | Unknown

• 1 other identifier: 2015-02-115
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

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

  baseline and 1.3 months

Study Arms (2)

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)

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)

Interventions

lateral rectus recession (bilateral) PROCEDURE

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.

conventional lateral rectus recession; hang-back lateral rectus recession

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Central Study Contacts

Sei Yeul Oh

CONTACT

821031115293

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 21, 2015

Record last verified: 2015-04