Intraocular PressureIOPICPTBINCT03344432
Correlation Intraocular Pressure With Intracranial Pressure
An observational study of Intraocular Pressure and Intracranial Pressure Increase, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Intraocular Pressure, Intracranial Pressure Increase, Trauma, Brain
- What is being tested?
- with intraocular pressure high and without intraocular pressure high
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jun 2015to 31 Dec 2019
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),
- who have been admitted to the pediatric emergency room
- and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.
Who cannot join
- Ocular trauma,
- brain death,
- know eye disease,
- refusal of parents or guardians to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Karla Isis Aviles-Martinez, PhD, 39424400, draisispediatra@yahoo.com.mx
Juan Luis Soto-Mancilla, Master, 39424400
About this study
Official title: Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury
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.
- Being tested
- with intraocular pressure high, without intraocular pressure high
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with intraocular pressure highDiagnostic test
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.
without intraocular pressure highDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| With intraocular pressure high | Intracranial pressure equal or more than 20 mmHg Receives: Diagnostic Test: with intraocular pressure high; Diagnostic Test: without intraocular pressure high | |
| Without intraocular pressure high | Intracranial pressure smaller than 20 mmHg Receives: Diagnostic Test: with intraocular pressure high; Diagnostic Test: without intraocular pressure high |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure smaller than 20 mmHg
Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.
Measured: 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
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Jun 2015
- Primary completion30 Nov 2017 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARLA ISIS AVILES MARTINEZ, Hospital Civil de Guadalajara
- Investigators
- Karla Isis I Aviles Martinez, PhD, Principal investigator, Hospital Civil Fray Antonio Alcalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344432
- Sponsor's protocol ID
- HCG/CI-0693/15
- Acronym
- IOPICPTBI
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury
- ClinicalTrials.gov ID
- NCT03344432
- Acronym / sponsor ID
- IOPICPTBI / HCG/CI-0693/15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With intraocular pressure high | – | Diagnostic Test: with intraocular pressure high, Diagnostic Test: without intraocular pressure highIntracranial pressure equal or more than 20 mmHg |
| Without intraocular pressure high | – | Diagnostic Test: with intraocular pressure high, Diagnostic Test: without intraocular pressure highIntracranial pressure smaller than 20 mmHg |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),
- who have been admitted to the pediatric emergency room
- and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.
Key exclusion criteria (4 listed)
- Ocular trauma,
- brain death,
- know eye disease,
- refusal of parents or guardians to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with intraocular pressure highMeasurement 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 test | With intraocular pressure high, Without intraocular pressure high |
| without intraocular pressure highMeasurement 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 test | With intraocular pressure high, Without intraocular pressure high |
Primary outcome
Intraocular pressure smaller than 20 mmHg
Time frame: Immediately
Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.
1 secondary outcome
Intraocular pressure equal or more than 20 mmHg
Time frame: Immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Isis I Aviles Martinez, PhD principal investigator
Hospital Civil Fray Antonio Alcalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Intracranial Pressure Increase, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karla Isis I Aviles-Martinez, PhD (39424400 ext. 48052, draisispediatra@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure smaller than 20 mmHg (time frame: Immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.