NCT02454920

Brief Summary

Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion measurement using calipers (gold standard).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

May 19, 2015

Last Update Submit

June 28, 2017

Conditions

Keywords

StrabismusOptical Coherence TomographyExtraocular muscles

Outcome Measures

Primary Outcomes (1)

  • Limbus to extraocular muscles insertion distance

    Measurement of the limbus to insertion distance with OCT

    Baseline measurement

Secondary Outcomes (1)

  • Comparison between intra operative and OCT measurements of the distance from the limbus to extraocular muscles insertion

    From date of baseline to date of surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients age greater then 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute

You may qualify if:

  • All patients age ≥ 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. Members of the study team will be involved in the clinical evaluation. The physician will determine if the patient has strabismus and whether strabismus surgery is advisable.

You may not qualify if:

  • Patient who is unwilling to participate the study.
  • A clinical scenario in which AS-OCT examination is not likely to be successful (e.g. an uncooperative patient).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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
  • Park KA, Lee JY, Oh SY. Reproducibility of horizontal extraocular muscle insertion distance in anterior segment optical coherence tomography and the effect of head position. J AAPOS. 2014 Feb;18(1):15-20. doi: 10.1016/j.jaapos.2013.11.005.

    PMID: 24568976BACKGROUND
  • Dai S, Kraft SP, Smith DR, Buncic JR. Ultrasound biomicroscopy in strabismus reoperations. J AAPOS. 2006 Jun;10(3):202-5. doi: 10.1016/j.jaapos.2006.01.209.

    PMID: 16814170BACKGROUND

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Hilda Capo, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share