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CompletedNCT03131245ONSDUpdated Oct 15, 2018

Optic Nerve Sheath Diameter in Craniosynostosis

An observational study in Optic Nerve Sheath Diameter, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
Up to 12 Years
Sex
All
01

Study summary

Changes of optic nerve sheath diameter after position changes

Read the detailed description

Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis

02

Conditions studied

  • Optic Nerve Sheath Diameter

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03

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children for correction of craniosyostosis

Inclusion criteria

  • craniosynostosis

Exclusion criteria

Exclusion Criteria:

  • infection on eye area
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. optic nerve sheath diameter

    optic nerve sheath diameter measure with ultrasound

    Time frame: 10 minutes after prone position

06

Study locations

1 site
  • SNUH
    Seoul, Jongro Gu 15710, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03131245
Lead sponsor
Seoul National University Hospital
Responsible party
Hee-Soo Kim (MD, PhD, Professor, Seoul National University Hospital) — Principal investigator
First posted
Apr 27, 2017
Start date
Jun 23, 2017
Primary completion
Jun 17, 2018
Completion
Jul 31, 2018
Last update
Oct 15, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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