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Status unknownNCT03344432IOPICPTBIUpdated Nov 17, 2017

Correlation Intraocular Pressure With Intracranial Pressure

An observational study in Intraocular Pressure, Intracranial Pressure Increase and Trauma, Brain, sponsored by Hospital Civil de Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Hospital Civil de Guadalajara · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
2 Years to 15 Years
Sex
All
01

Study summary

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

Read the detailed description

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

Material and methods. Correlation and diagnostic test design study. Inclusion criteria: children with TBIs admitted to the emergency room and indication of catheter for ICP measurement.

Exclusion criteria: injury or ophthalmic disease, glaucoma, encephalic death. Intraocular pressure was measured with electronic tonometer in both eyes prior to placement of the catheter for ICP measurement.

Correlation was estimated with Spearman's Rho. The utility values of the diagnostic test were obtained from an Receiver Operating Characteristic curve.

02

Conditions studied

  • Intraocular Pressure
  • Intracranial Pressure Increase
  • Trauma, Brain
  • Children, Only
03

In context

Intracranial Hypertension

165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 76 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children of 2 at 15 years old with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points), in pediatric emergency room, with indication by the neurosurgeon to place a invasive catheter for intracranial pressure measurement.

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

  1. Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),
  2. who have been admitted to the pediatric emergency room
  3. and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.

Exclusion criteria

Exclusion Criteria:

  1. Ocular trauma,
  2. brain death,
  3. know eye disease,
  4. refusal of parents or guardians to participate in the study.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • With intraocular pressure high

    Intracranial pressure equal or more than 20 mmHg

    Diagnostic Test: with intraocular pressure high · Diagnostic Test: without intraocular pressure high

  • Without intraocular pressure high

    Intracranial pressure smaller than 20 mmHg

    Diagnostic Test: with intraocular pressure high · Diagnostic Test: without intraocular pressure high

Interventions

  • Diagnostic testwith intraocular pressure high

    Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.

  • Diagnostic testwithout intraocular pressure high

    Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.

06

What researchers measure

Primary outcomes

  1. Intraocular pressure smaller than 20 mmHg

    Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.

    Time frame: Immediately

Secondary outcomes

  1. Intraocular pressure equal or more than 20 mmHg

    Intraocular pressure equal or more than 20 mmHg with Intracranial pressure equal or more than 20 mmHg

    Time frame: Immediately

07

Study locations

1 of 1 sites recruiting
  • Hospital Civil Fray Antonio Alcalde
    Guadalajara, Jalisco 44280, Mexico
    Recruiting
    • Karla Isis Aviles-Martinez, PhD · Contactdraisispediatra@yahoo.com.mx · 39424400
    • Juan Luis Soto-Mancilla, Master · Contact39424400
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2015 (actual). Primary completion is estimated for Nov 2017, 29 months after the start.

Of 42 non-industry observational studies under Intracranial Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 29 months is close to that.

Counting every sponsor, half of 44 studies reached it within 31 months; a quarter within 11 and three quarters within 62.

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

Registered
Nov 12, 2017
First posted
Nov 17, 2017
StartActual
Jun 10, 2015
Primary completionEst.
Nov 30, 2017
CompletionEst.
Dec 31, 2019
Last update
Nov 17, 2017
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 Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03344432
Lead sponsor
Hospital Civil de Guadalajara
Responsible party
KARLA ISIS AVILES MARTINEZ (Dra. Karla Isis Avilés-Martínez, Hospital Civil de Guadalajara) — Principal investigator
First posted
Nov 17, 2017
Start date
Jun 10, 2015
Primary completion
Nov 30, 2017 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Nov 17, 2017

Study contacts

Karla Isis I Aviles-Martinez, PhD
Contact
draisispediatra@yahoo.com.mx
39424400 ext. 48052
Adriana López-Enríquez, MD
Contact
aleurg2@hotmail.com
39424400 ext. 48051
Karla Isis I Aviles Martinez, PhD
principal investigator · Hospital Civil Fray Antonio Alcalde

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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