NCT02383381

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

March 9, 2015

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

February 24, 2015

Last Update Submit

March 3, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

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

    baseline and 1.3.6 months

Interventions

typical surgery for correcting intermittent exotropia

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients : 21 males and 9 females age: 9 to 60 years

You may qualify if:

  • patients who underwent lateral rectus recession surgery for correcting intermittent exotropia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liu X, Wang F, Xiao Y, Ye X, Hou L. Measurement of the limbus-insertion distance in adult strabismus patients with anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Oct 28;52(11):8370-3. doi: 10.1167/iovs.11-7752.

    PMID: 21948556BACKGROUND

Related Links

Study Design

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

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 9, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 9, 2015

Record last verified: 2014-02