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Status unknownNCT02450162AS-OCTUpdated May 21, 2015

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

An observational study in Intermittent Exotropia, sponsored by Samsung Medical Center. Status unknown. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
5 Years to 60 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Intermittent Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

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Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous ocular surgery
  • other ocular diseases except intermittent exotropia
  • amblyopia
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurelateral 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.

06

What researchers measure

Primary outcomes

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

    Time frame: baseline and 1.3 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Aug 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2015
First posted
May 21, 2015
Start
May 2015
Primary completionEst.
Aug 2015
CompletionEst.
Dec 2015
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02450162
Responsible party
Sponsor
First posted
May 21, 2015
Start date
May 2015
Primary completion
Aug 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 21, 2015

Study contacts

Sei Yeul Oh
Contact
821031115293

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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