GlaucomaEarly Phase 1IOPNCT01925391
The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops
A Early Phase 1 study testing Tono-pen XL Applanation tonometer + Ocu-film + in people with Glaucoma and Intraocular Pressure, run by University of Miami at 2 sites in United States.
Trial summary
Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Anesthesia
- What is being tested?
- Tono-pen XL Applanation tonometer + Ocu-film +
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to May 2014
- Phase
- Early Phase 1
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male or female from 1 year of age to less than 18 years of age
- Out-patients scheduled to undergo examination under anesthesia
- out-patients scheduled to undergo eye surgery for strabismus or oculoplastic procedure.
- ASA status I or II
- female patients who have attained menarche must have negative pregnancy tests at screening
Who cannot join
- patients that have contraindications to the use of nitrous oxide in oxygen
- glaucoma patients
- patients in whom IOP cannot be measured accurately
- latex allergy patients
- patients allergic to aminoesthers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Bascom Palmer Eye Hospital
Miami, Florida, 33125
Bascom Palmer Eye Hospital
Miami, Florida, 33138
About this study
Official title: The Measurement of Intraocular Pressure in Nonglaucomatous Children Under Nitrous Oxide/02/Topical Anesthesia and Sevoflurane/Nitrous Oxide/Topical Anesthesia
Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible to obtain in an office setting. Children need sedation or general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.
Read the detailed description
The investigator's intention is to measure the IOP under nitrous oxide in Oxygen followed by measurements under Sevoflurane in a population of children without glaucoma who are already scheduled to undergo general anesthesia for an elective eye surgery. Normally, induction and maintenance of general anesthesia in children includes the addition of volatile anesthetics such as Sevoflurane. The investigators hypothesize that in children, Nitrous oxide will affect IOP from pre-anesthetic baseline minimally. Hence, when sequential IOP measurements are taken in short intervals ( every 30 seconds times 3), there will be minimal changes during the initial nitrous oxide phase of the induction when compared to the subsequent addition of Sevoflurane.
Subject's parents will be consented and if the subject is old enough to understand the procedure, we will have them also sign an assent to the participation of this study.The child will be randomized to either the nitrous oxide in oxygen and Sevoflurane group or the Nitrous oxide in oxygen alone group or Sevoflurane in oxygen group without Nitrous oxide in the inhalational anesthetic mix.
Subjects will be pre-treated with midazolam via oral administration as a dose of 0.5 - 1 mg/kg not to exceed 20 mg total. If they present with an intravenous line, they will be pre-treated with midazolam at 0.05 - 0.1 mg/kg. All patients receiving preoperative sedation will be monitored as per ASA procedural sedation guidelines.
Once the subject is bought into the operating room, all ASA mandatory vital sign monitors will be connected and tetracaine eye drops ( a fast acting topical anesthetic solution) will be placed on the subject's right eye. The rapid clearance of this short acting topical anesthetic reduces any potential risk for systemic toxicity. Once the drops are in,inhalation induction will begin and an initial attempt at measuring IOP will begin when the pediatric anesthesiologist deems the patient is ready clinically.all vital signs and IOP Measurements will be repeated every 30 seconds three times and recorded for data analysis. Once these measurements are recorded, the case will proceed as scheduled and planned.
- Conditions
- Glaucoma, Intraocular Pressure, Anesthesia
- Being tested
- Tono-pen XL Applanation tonometer + Ocu-film +
- Keywords
- Pediatric glaucoma, Intraocular pressure, pediatric glaucoma diagnosis, Volatiles and intraocular pressure, nitrous oxide, Tetracaine
- Medical subject headings
- Glaucoma, Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tono-pen XL Applanation tonometer + Ocu-film +Drug
Also called Tono-pen Applanation tonometer, Reichert Technologies
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane, oxygen, intraocular pressure | Active comparator | Intraocular measurements under induction with Sevoflurane in oxygen Receives: Drug: Tono-pen XL Applanation tonometer + Ocu-film + |
| Nitrous oxide/O2/tetracaine | Active comparator | intraocular pressures in children undergoing inhalation induction with nitrous oxide in oxygen Receives: Drug: Tono-pen XL Applanation tonometer + Ocu-film + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia.
The investigator's intention is to measure IOP in children, who otherwise will be undergoing elective surgery, under nitrous oxide in oxygen and compare those measurements with those going under anesthesia with Sevoflurane in oxygen. The investigators hypothesize that children pre-sedated for surgery,cooperate with topical eye anesthetics and nitrous oxide in oxygen for IOP measurements and results may reflect pre-anesthetic baseline pressures when compared with an induction with Sevoflurane in oxygen.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline L Tutiven, University of Miami
- Investigators
- Jacqueline L tutiven, Md, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925391
- Sponsor's protocol ID
- 20120451
- Acronym
- IOP
- Status last verified
- Jun 2014
- First submitted
- 12 Aug 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Intraocular Pressure in Nonglaucomatous Children Under Nitrous Oxide/02/Topical Anesthesia and Sevoflurane/Nitrous Oxide/Topical Anesthesia
- ClinicalTrials.gov ID
- NCT01925391
- Acronym / sponsor ID
- IOP / 20120451
- Conditions
- Glaucoma, Intraocular Pressure, Anesthesia
- Keywords
- Pediatric glaucoma, Intraocular pressure, pediatric glaucoma diagnosis, Volatiles and intraocular pressure, nitrous oxide, Tetracaine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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.
Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible to obtain in an office setting. Children need sedation or general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.
Detailed description
The investigator's intention is to measure the IOP under nitrous oxide in Oxygen followed by measurements under Sevoflurane in a population of children without glaucoma who are already scheduled to undergo general anesthesia for an elective eye surgery. Normally, induction and maintenance of general anesthesia in children includes the addition of volatile anesthetics such as Sevoflurane. The investigators hypothesize that in children, Nitrous oxide will affect IOP from pre-anesthetic baseline minimally. Hence, when sequential IOP measurements are taken in short intervals ( every 30 seconds times 3), there will be minimal changes during the initial nitrous oxide phase of the induction when compared to the subsequent addition of Sevoflurane.
Subject's parents will be consented and if the subject is old enough to understand the procedure, we will have them also sign an assent to the participation of this study.The child will be randomized to either the nitrous oxide in oxygen and Sevoflurane group or the Nitrous oxide in oxygen alone group or Sevoflurane in oxygen group without Nitrous oxide in the inhalational anesthetic mix.
Subjects will be pre-treated with midazolam via oral administration as a dose of 0.5 - 1 mg/kg not to exceed 20 mg total. If they present with an intravenous line, they will be pre-treated with midazolam at 0.05 - 0.1 mg/kg. All patients receiving preoperative sedation will be monitored as per ASA procedural sedation guidelines.
Once the subject is bought into the operating room, all ASA mandatory vital sign monitors will be connected and tetracaine eye drops ( a fast acting topical anesthetic solution) will be placed on the subject's right eye. The rapid clearance of this short acting topical anesthetic reduces any potential risk for systemic toxicity. Once the drops are in,inhalation induction will begin and an initial attempt at measuring IOP will begin when the pediatric anesthesiologist deems the patient is ready clinically.all vital signs and IOP Measurements will be repeated every 30 seconds three times and recorded for data analysis. Once these measurements are recorded, the case will proceed as scheduled and planned.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane, oxygen, intraocular pressure | Active comparator | Drug: Tono-pen XL Applanation tonometer + Ocu-film +Intraocular measurements under induction with Sevoflurane in oxygen |
| Nitrous oxide/O2/tetracaine | Active comparator | Drug: Tono-pen XL Applanation tonometer + Ocu-film +intraocular pressures in children undergoing inhalation induction with nitrous oxide in oxygen |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- male or female from 1 year of age to less than 18 years of age
- Out-patients scheduled to undergo examination under anesthesia
- out-patients scheduled to undergo eye surgery for strabismus or oculoplastic procedure.
- ASA status I or II
- female patients who have attained menarche must have negative pregnancy tests at screening
Key exclusion criteria (5 listed)
- patients that have contraindications to the use of nitrous oxide in oxygen
- glaucoma patients
- patients in whom IOP cannot be measured accurately
- latex allergy patients
- patients allergic to aminoesthers
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 |
|---|---|---|
| Tono-pen XL Applanation tonometer + Ocu-film +Also: Tono-pen Applanation tonometer, Reichert Technologies | Drug | Nitrous oxide/O2/tetracaine, Sevoflurane, oxygen, intraocular pressure |
Primary outcome
Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia.
Time frame: Up to 40 weeks
The investigator's intention is to measure IOP in children, who otherwise will be undergoing elective surgery, under nitrous oxide in oxygen and compare those measurements with those going under anesthesia with Sevoflurane in oxygen. The investigators hypothesize that children pre-sedated for surgery,cooperate with topical eye anesthetics and nitrous oxide in oxygen for IOP measurements and results may reflect pre-anesthetic baseline pressures when compared with an induction with Sevoflurane in oxygen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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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.
Jacqueline L tutiven, Md principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tono-pen XL Applanation tonometer + Ocu-film + in people with Glaucoma and Intraocular Pressure, run by University of Miami at 2 sites in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia. (time frame: Up to 40 weeks). 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 16 Jun 2014.